Non-invasive pressure-mitigation apparatuses for improving blood flow and associated systems and methods

ABSTRACT

Introduced here are apparatuses and systems for mitigating contact pressures applied to a human body by the surface of an object, such as a chair, bed, or table. A pressure-mitigation apparatus can include a series of chambers whose pressure can be individually varied. When placed between a patient and a contact surface, the pressure-mitigation apparatus can vary the contact pressure on a specific anatomical region of the patient by controllably inflating and/or deflating one or more cell. Moreover, a pressure-mitigation system can be readily integrated into a conventional treatment regimen for a variety of different conditions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 15/905,649, filed on Feb. 26, 2018, which is a continuation ofU.S. patent application Ser. No. 14/313,570, filed on Jun. 24, 2014 andissued as U.S. Pat. No. 9,901,491 on Feb. 27, 2018, which is acontinuation of U.S. patent application Ser. No. 14/063,861, filed onOct. 25, 2013 and issued as U.S. Pat. No. 8,757,165 on Jun. 24, 2014.U.S. Pat. No. 8,757,165 is a continuation-in-part of U.S. patentapplication Ser. No. 13/660,429, filed on Oct. 25, 2012, which claimspriority to U.S. Provisional Patent Application No. 61/618,936, filed onApr. 2, 2012. In addition, this application claims priority to U.S.Provisional Application No. 62/647,551, filed on Mar. 23, 2018. Each ofthese applications is incorporated by reference herein in its theirentirety.

This application is related to U.S. Pat. No. 9,931,238, filed May 19,2014, which is a continuation of U.S. Pat. No. 8,726,908, filed on Oct.25, 2013. Each of these applications is incorporated by reference hereinin its entirety.

TECHNICAL FIELD

The present technology relates generally to non-invasive apparatuses,systems, and methods for mitigating the contact pressure applied to ahuman body by a support surface.

BACKGROUND

Pressure injuries, sometimes referred to as decubitus ulcers, pressureulcers, pressure sores, or bedsores, are a frequent but often avoidablecomplication in many mobility-impaired individuals. These pressureulcers typically occur as a result of steady pressure in one locationalong the surface of the human body such as, for example, the sacrum.These pressure ulcers are most common in individuals who aremobility-impaired or immobilized (e.g., in a wheelchair or a bed, or onan operating table) for prolonged periods of time. Oftentimes thesepatients are older, malnourished, and/or incontinent, all factorspredisposing patients to pressure injury formation. Because thesepatients are often not ambulatory, they may sit or lie for prolongedperiods of time in the same position. These individuals often are unableto reposition themselves to alleviate the pressure. Consequently, thepressure on the skin and soft tissue eventually causes ischemia orinadequate blood flow to the area, thereby resulting in breakdown of theskin and tissue damage. Pressure injuries can result in a superficialinjury to the skin, or a deeper full-thickness ulcer that exposesunderlying tissues and places the individual at risk for infection. Theresulting infection may worsen, leading to sepsis, or even death in somecases.

There are many support surfaces on the market for preventing pressureulcers. However, conventional support surfaces have many deficiencies,including the inability to control the spatial relationship between thepatient and the therapeutic surface or contact surface. Consequently,patients using conventional support surfaces may still end up withpressure ulcers or related complications.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on clearlyillustrating the principles of the present disclosure. Furthermore,components may be shown as transparent in certain views for the purposeof illustration, rather than to indicate that the component isnecessarily transparent. Any headings provided herein are forconvenience only.

FIG. 1 depicts a side view of an example system for orienting a patientover an anatomy-specific pressure-mitigating contact surface on whichthe patient rests, according to an embodiment.

FIG. 2 depicts an example pressure mitigation support apparatus,according to an embodiment.

FIG. 3A and FIG. 3B depict top and side views, respectively, of anexample system for orienting a patient over an anatomy-specificpressure-mitigating support surface on which a patient rests, accordingto an embodiment.

FIG. 4A and FIG. 4B depict top and cross-sectional views, respectively,of an example pressure mitigation support apparatus, according to anembodiment.

FIG. 5 depicts an example pressure mitigation support apparatus,according to an embodiment.

FIG. 6 depicts a flow chart illustrating an example process forcoordinated chamber inflation and deflation of a therapeutic surfacewhile the spatial relationship between the patient and the therapeuticsurface is controlled by the side-walls of the therapeutic surface.

FIG. 7 depicts a schematic diagram illustrating an example pressuremitigation support apparatus, according to an embodiment.

FIG. 8 depicts a side view of an example system for orienting a patientover an anatomy-specific pressure-mitigating contact surface with lowerextremity wedge on which the patient rests, according to an embodiment.

FIG. 9 is a partially schematic top view of a pressure-mitigationapparatus illustrating varied pressure distributions for avoidingischemia for a mobility impaired patient in accordance with embodimentsof the present technology.

FIG. 10A is a partially schematic side view of a pressure-mitigationapparatus for relieving pressure on a specific anatomical region bydeflating at least one chamber in accordance with embodiments of thepresent technology.

FIG. 10B is a partially schematic side view of a pressure-mitigationapparatus for relieving pressure on a specific anatomical region byinflating at least one chamber in accordance with embodiments of thepresent technology.

FIG. 11 is a flow diagram of a process for treating a condition using apressure-mitigation system in accordance with embodiments of the presenttechnology.

FIG. 12 is a block diagram illustrating an example of a processingsystem in which at least some operations described herein can beimplemented.

DETAILED DESCRIPTION

Pressure injuries (also referred to as “ulcers”) are localized regionsof damage to the skin and/or underlying tissue that result from contactpressure (or simply “pressure”) on the corresponding anatomical regionof the body. Pressure injuries often form over bony prominences, such asthe skin and soft tissue overlying the sacrum, coccyx, heels, or hips.However, other sites (e.g., elbows, knees, ankles, shoulders, abdomen,back, or cranium) may also be affected. Generally, pressure injuriesoccur when pressure is applied to blood vessels in soft tissue, which atleast partially obstructs blood flow to the soft tissue and can lead toischemia at the pressure site for an extended duration (e.g., when thepressure exceeds the capillary filling pressure). Therefore, pressureinjuries often occur in humans who are mobility impaired, immobilized,or sedentary for prolonged periods of times. When pressure is relievedfrom the site of the pressure injury, the body rushes blood to thatregion to re-perfuse the area. The sudden reperfusion of the damaged,previously ischemic region has been shown to cause a reperfusion injury,characterized by a profound inflammatory response involving the releaseof proinflammatory mediators. This pathogenic process can actuallyworsen the original pressure injury and may spread through the bloodstream beyond the site of the initial ischemic insult to cause asystemic inflammatory response. The presence of proinflammatorymediators has been shown to exacerbate existing conditions or triggeradditional ailments, thereby slowing patient recovery. Moreover, patientrecovery time can be prolonged by numerous factors often associated withpatients prone to pressure injuries, such as old age, immobility,preexisting medical conditions (e.g., arteriosclerosis, diabetes, orinfection), smoking, and/or medications (e.g., anti-inflammatory drugs).Thus, preventing or reducing pressure injury formation and reducingproinflammatory mediators can enhance and expedite many treatmentprocesses for patients, especially those who are mobility-impairedduring the course of treatment.

Introduced here, therefore, are apparatuses and systems for mitigatingthe pressure applied to a human body by the surface of an object, suchas a chair, bed, table, or other support surface. A non-invasivepressure-mitigation or perfusion enhancement apparatus (also referred toas a “pressure-mitigation device,” a “pressure-mitigation pad,” or a“perfusion enhancement apparatus”) can include a series of chambers(also referred to as “cells”) whose pressure can be individually varied.When placed between a patient and a contact surface (e.g., a bed or achair), the pressure-mitigation apparatus can vary the pressure on oneor more specific anatomical regions of the patient by controllablyinflating one or more chambers, deflating one or more chambers, or anycombination thereof.

Specific details of several embodiments of the present technology aredescribed herein with reference to FIGS. 1-12. Although many of theembodiments are described with respect to apparatuses, systems, andmethods for alleviating the pressure applied to a human body in a supineposition by a contact surface, other embodiments in addition to thosedescribed herein are within the scope of the present technology. Forexample, at least some embodiments of the present technology may beuseful for alleviating the pressure applied to a human body in a sittingposition. In such embodiments, the chambers of the pressure-mitigationapparatus may be inflated in a different order, with differentpressures, for different durations, etc.

It should be noted that other embodiments in addition to those disclosedherein are within the scope of the present technology. For example,components, configurations, and/or procedures shown or described withrespect to one embodiment can be combined with or replace thecomponents, configurations, and/or procedures described in otherembodiments. Further, embodiments of the present technology can havedifferent configurations, components, and/or procedures than those shownor described herein. Moreover, a person of ordinary skill in the artwill understand that embodiments of the present technology can haveconfigurations, components, and/or procedures in addition to those shownor described herein, and that these and other embodiments can be withoutseveral of the configurations, components, and/or procedures shown ordescribed herein without deviating from the present technology.

Selected Embodiments of Pressure-Mitigation Apparatuses

Embodiments of the present disclosure include examples of systems,methods, and apparatuses for the prevention and treatment of pressureinjuries. In particular, the pressure injury prevention systems and/orapparatuses (also referred to as “perfusion enhancement systems”)disclosed herein prevent or otherwise mitigate pressure injuries byactively orienting a patient over an anatomy-specificpressure-mitigating contact surface on which the patient rests. Apressure-mitigating contact portion of the contact surface includes aplurality of independently pressurized chambers configured in a specificgeometric pattern that is designed to mitigate contact pressure betweena support surface (e.g., bed or chair) and a specific anatomic region ofa patient's body when the specific anatomic region of the patient's bodyis oriented over an epicenter of the geometric pattern.

In one embodiment, the pressure injury prevention systems and/orapparatuses control pressure beneath specific anatomic locations of thepatient for specific durations in order to move pressure points aroundthe anatomy in a precise manner such that specific portions of theanatomy (e.g., tissue adjacent bony prominences) have zero pressureapplied for predetermined periods of time. This continuous orintermittent relocation of the pressure point(s) avoids vascularcompression for sustained periods of time and, therefore, inhibitsischemia and ultimately reduces the incidence of pressure injuries.Thus, the pressure injury prevention systems and/or apparatuses make itpossible to increase and decrease the pressure beneath a patient atspecific locations for set periods of time in order to maximize thepotential therapeutic benefits of a therapeutic surface.

In one embodiment, the pressure injury prevention systems and/orapparatuses are specifically designed for mitigating pressure and/orotherwise preventing prolonged vasocompression to avoid ischemia,reperfusion injury, and the associated health implications (e.g.,pressure injuries) in the sacral area or region of the human anatomy.This is unlike prior art surfaces or overlays that are typically placedbeneath the entire length of the patient and do not function based onbeing uniquely oriented beneath a specific location (or anatomic region)of the patient.

In one embodiment, the geometric pattern is designed and/or shapedaccording to general human anatomy and/or the individual patient'sspecific anatomy. For example, if the pressure injury prevention systemsand/or apparatuses are designed to mitigate contact pressure between asupport surface and the patient's sacral region then the independentlypressurized chambers are designed in specific shapes to fit to thepatient's pelvic bones, the gluteus muscles, and/or the sacral arties.In one embodiment, the geometric pattern is symmetric and non-repeatingin nature.

In one embodiment, the device's patient contact portion is designed toactively orient the patient over the support surface portion in a waythat allows an apparatus to “know” for the first time the location ofthe patient on that device. The apparatus is designed to take advantageof this knowledge regarding the location of the patient to moreeffectively mitigate and systematically rotate the damaging pressurethat leads to the formation of pressure injuries.

In one embodiment, the apparatuses described herein comprise mattressoverlay devices. The described overly devices differ from the prior artmattress overlays that cover the full surface of the bed. Further, theprior art mattress overlays typically have a repeating patternthroughout and allow a patient to freely move about over the entiresurface of the bed. Conversely, the apparatuses described herein areanatomy-specific and may only be the size of the patient's anatomy thatmakes contact with the apparatus. Accordingly, the disclosed systems,methods, and apparatuses take advantage of the inherent knowledge of thepatient's location on the anatomy-specific pressure-mitigating contactsurface to systematically rotate and/or otherwise alternate the damagingpressure that leads to the formation of pressure.

In one embodiment, the patient can be actively oriented over ananatomy-specific pressure-mitigating contact surface by controlling thespatial relationship between the patient and the contact surface throughthe use of one or more side support portions. In some embodiments, theside support portions may be inflatable. In other embodiments, the sidesupport portions are fixed. In the former case, the side supportportions may be independently inflated with any appropriate gas orliquid. The inflation of the side support portions is independent of thepressurized relief chambers on the pressure-mitigating contact portion.In some embodiments, the side support portions may be inflatedindependent of each other in order to properly orient the patient. Thiscan be based on the actual pressure in a side support portion versus anexpected pressure in that side support portion as determined by acontrol device. Alternatively or additionally, one or more sensors canbe built into the side support portions that identify discrepancies inthe ideal position of the patient on the anatomy-specificpressure-mitigating contact surface and attempt to adjust the patientaccordingly (e.g., by independently adjusting the pressure in the sidesupport portions).

In one embodiment, the pressure in the side support portions is fixed.In this case, the fixed side support portions may be fixed using aliquid, a gas, and/or a solid. In the case where a solid is used,Styrofoam, and/or any “cushion like” materials can be utilized. The sidesupport portions may be elevated in height above the anatomy-specificpressure-mitigating contact surface in order to prevent a patient fromlateral movement (i.e., movement along the x-axis). For example, theside support portions may be elevated, when inflated, two to threeinches in vertical height above the average surface height of thepressure-mitigating contact portion.

Further, to prevent movement along the y-axis the anatomy-specificpressure-mitigating contact surface may be designed such that a specificportion of the contact surface is aligned over the surface of a V formedin a patient's hospital bed. In one embodiment, the side supportportions may be attached to the sides of a pressure-mitigating contactportion. In one embodiment, the side support portions may be configuredwith a recess configured to accommodate a patient's elbow. The recessthat accommodates the patient's elbow results in a more comfortabledevice that offloads pressure over the elbow of the patient.

In one embodiment, the design of the pressure injury prevention systemsand/or apparatuses disclosed herein take into account and/or control forvarious factors that influence functionality and/or effectiveness of thepressure injury prevention systems and/or apparatuses. For example, thesystems and/or apparatuses may take time, space, patient weight, patientposition, real-time interface pressure, existing conditions (e.g.,existing pressure injuries), and/or human anatomy into account in theprevention of pressure injuries.

In one embodiment, the systems and/or apparatuses may be employed as amattress overlay. For example, the overlay device or apparatus could bedeployed on any mattress, chair, or other support surface. Alternativelyor additionally, the systems and/or apparatuses may be incorporated intothe design of a mattress.

In one embodiment, the surface area of the pressure relief surface isdesigned to match (or be less than) the size of the patient's surfaceanatomy in the region of contact made between the patient's anatomicregion and the device. For example, the size of the pressure reliefsurface may be the size of the patient's surface anatomy in the regionof contact made between the patient's sacral region and the pressuremitigation support apparatus. Further, the pressure relief surface maybe contoured to fit the surface topography of the patient's surfaceanatomy in the region of contact made between the patient's sacralregion and the pressure mitigation support apparatus. The internalanatomy is considered in the pattern—not the height—of the reliefchamber design.

In one embodiment, the pressure relief apparatus is designed such thatno portion of the independently pressurized relief chambers of thesurface area of the pressure relief surface in contact with the patientis left uncovered by the patient. That is, the independently pressurizedrelief chambers in contact with the patient can be smaller than or equalto but not larger than the area of contact with the patient. Thisfeature improves performance of the pressure relief apparatusesdescribed herein. Conversely, with prior art standard alternatingpressure overlays, the pressure relieving air cells are much larger thanthe contact area with the patient and therefore the air cells are onlypartially covered by of the patient. Thus, with prior art designs, theuncovered portions of the pressure relieving air cells act as areservoir “sink” for the inflated air and minimize the liftingcapabilities of these surfaces that are needed to create areas of lowpressure fundamental to the optimal functioning of such a device.

In one embodiment, the independently pressurized relief chambers of thepressure relief apparatus are unique in that the entirety of the surfacearea of the independently pressurized relief chambers are in contactwith the patient such that no portion of the independently pressurizedrelief chambers is left uncovered by the user. Therefore, in thisembodiment, the individual independently pressurized relief chambers ofthe pressure relief apparatus can be smaller than or equal to but notlarger than the area of contact with the patient. This feature canimprove performance of the pressure relief apparatus. In the case ofprior art standard alternating pressure overlays, the pressure relievingair cells are much larger than the contact area with the patient andtherefore the air cells are only partially covered by of the patient.Thus, with prior art designs, the uncovered portions of the pressurerelieving air cells act as a reservoir “sink” for the inflated air andminimize the lifting capabilities of these surfaces that are needed tocreate areas of low pressure fundamental to the optimal functioning ofsuch a device.

In one embodiment, the systems and/or apparatuses can be employed as amattress overlay and/or incorporated into the design of a mattressitself. The overlay can be deployed on any mattress or chair. The designof the pressure mitigation surface portion of the overlay portion of thedevice takes into account multiple factors. These factors includepatient comfort, patient anatomy, patient position (seated, flat, 30degrees head up), and anatomic locations with a propensity to developpressure injuries.

It is appreciated that the term “patient” as used herein can include anyindividuals, users or persons that are mobility impaired for prolongedperiods of time and thus susceptible to pressure injuries.

FIG. 1 depicts a side view of an example system 100 for orienting apatient over an anatomy-specific pressure-mitigating contact surface onwhich the patient rests, according to an embodiment. The example system100 includes a patient 110, a support surface 115, a pressure mitigationsupport apparatus 120 and a control device 130. A more detailed exampleof a specific pressure mitigation support apparatus (e.g., partial bodyalternating contact pressure mattress overlay device) is shown anddiscussed in greater detail with respect to FIG. 2.

In the example of FIG. 1, the pressure mitigation support apparatus 120is comprised of two elevated side support portions 125, apressure-mitigating contact portion (shown in FIG. 2), and straps 126.The pressure-mitigating contact portion includes a plurality ofindependently pressurized relief chambers interconnected on a basematerial. As described herein, the independently pressurized reliefchambers are configured in a geometric pattern that mitigates contactpressure between the support surface 115 and a specific anatomic regionof a patient's body when the specific anatomic region of the patient'sbody is oriented over an epicenter of the geometric pattern. The supportsurface 115 may be a hospital bed, a mattress, and/or other surface onwhich a patient is positioned in at least partially supine position.

The elevated side support portions 125 are configured to actively orientthe specific anatomic region of the patient's body over the epicenter ofthe geometric pattern. As shown, the specific anatomic region of thepatient's body is the sacral region. However, it is appreciated that thespecific anatomic region can be any specific region of the patient'sbody that is susceptible to pressure injuries (e.g., ulcers). The sidesupport portions 125 are configured so as to be ergonomically correct.For example, the side support portions 125 may be configured with arecess to accommodate the patient's elbows in some embodiments resultingin a more comfortable apparatus that off loads pressure over the elbowof the patient.

The elevated side support portions 125 can be significantly larger insize as compared to the size of the pressure relief surface air cells.As a result, the elevated side support portions 125 create a barrierthat keeps a patient from moving laterally or sideways off of theanatomy-specific pressure-mitigating contact surface. In one embodiment,the elevated side support portions 125 may be on average at least 2-3inches taller in vertical height after inflation as compared to theaverage height of the inflated (or pressurized) pressure-mitigatingcontact portion. Because the elevated side support portions 125 arelarger and do not go underneath the patient, but instead straddle thesides of the patient, the elevated side support portions 125 act to holdand position the patient on top of the anatomy-specificpressure-mitigating contact surface.

The straps 126 are configured to secure the pressure mitigation supportapparatus to the support surface.

In one embodiment, inner side walls of the elevated side supportportions 125, on initial inflation of higher pressure, form a firmsurface at a steep angle of orientation with respect to the patient onthe pressure mitigation support apparatus 120. For example, the innerside walls may be on a plane of 115 degrees plus or minus 25 degreesfrom the plane of the pressure mitigation support apparatus 120. Thesesteep inner side walls create a steeply angled side wall down which thepatient, when positioned inappropriately off to one side or another,will slide down toward an epicenter of a geometric pattern formed on thepressure mitigation support apparatus 120. Thus, inflation orpressurization of the elevated side support portions 125 actively forcesthe patient into a position ideal for the mitigation of pressure byorienting the user in the correct position over the pressure mitigationsupport apparatus 120. As a result, the patient's anatomy will becorrectly aligned with respect to the x-axis.

Once the initial inflation cycle has finished and the user is properlypositioned, the internal pressures of the elevated side support portions125 may decrease to a lower pressure to increase comfort and preventexcessive force against the lateral aspect of the patient. Ideally, acaregiver of the patient will be present during the initial positioningof the patient over the pressure mitigation support apparatus 120 toensure proper positioning of the patient by the elevated side supportportions 125.

In one embodiment, the elevated side support portions 125 comprisesteeply angled side walls. For example, the walls may be angled suchthat the inner aspect of the elevated side support portions 125 whichcontact the user on the lateral aspects of each hip/thigh regionsimultaneously will form an obtuse angle of between 90 to 145 degreeswith respect to the plane of the pressure mitigation support apparatus120 (i.e., a pressure-mitigating contact portion). The elevated sidesupport portions 125 may be connected by pressure channels (e.g., airchannels).

In one embodiment, the elevated side support portions 125 are inflatedand deflated in series together. Thus, like the independentlypressurized relief chambers, the air pressure in the elevated sidesupport portions 125 can be controlled by the control device 130.Alternatively or additionally, each side support portion of the elevatedside support portions 125 can be controlled by a unique control deviceand/or pump within the pump housing. The pressures within the elevatedside support portions 125 can be determined based on pre-set parametersof the individual pump cycle as determined on an individual patientspecific basis (e.g., individual parameters based on the weight,existing pressure injuries, and/or position of the patient).

In one embodiment, there can be one or more air (or pressure) channels(not shown) between the elevated side support portions 125. In somecases, the air channels can be redundant. Redundancy of air channelsallows for even distribution of air (or other pressure) between theelevated side support portions 125. For example, one air channel maytraverse the outside (or perimeter) of the pressure mitigation supportapparatus 120 to the top of the apparatus while a second air channeltraverse the outside of the pressure mitigation support apparatus 120 alower edge of the apparatus. This configuration or arrangement creates aclosed loop circle around the pressure mitigation support apparatus 120which allows air to pass unobstructed from the pump into a first one ofthe elevated side support portions 125 through the connecting airchannels and into a second one of the elevated side support portions 125without the weight of the patient blocking both channels simultaneouslyas this is physically improbable with the redundant configurationdescribed herein.

In one embodiment, the pressure channels can flare out slightly at thepoint of entry into the elevated side support portions 125 so as toreduce the likelihood of kinking or otherwise disturbing the inflationand/or pressurization of the pressure channels.

In one embodiment, the pressure mitigation support apparatus 120 canhave an additional elevated side support portion 125 that is positionedbetween the legs of a patient along the lower aspect of the pressuremitigation support apparatus 120 (not shown). This additional elevatedside support portion 125 can prevent a patient from migration toward thefoot of the bed in the y-axis.

In one embodiment, the elevated side support portions 125 function muchlike the side arms of a chair which has a seat portion that is the samesize as the “seat” of the user (e.g., a chair that is too small for auser). These side arms allow only a small lateral position shift of theuser. As is the case with the pressure mitigation support apparatus 120,this minimal lateral motion is not great enough to allow the user todisplace their location off of the pressure mitigation support apparatus120 to a degree that will render the pressure relief characteristicsless effective.

The control system 130 is configured to regulate the pressure of each ofthe independently pressurized relief chambers via a pressure device 132(e.g., air pump) and multi-channel tubing 135. For example, theindependently pressurized relief chambers may be controlled in aspecific pattern to preserve blood flow by reducing contact pressure inspecific, varying locations when inflated (pressurized) and deflated(depressurized) in a coordinated fashion that is controlled by thecontrol device 130. The multi-channel tubing 135 connects the pressuremitigation support apparatus 120 with the air pump control system 130.One or more connectors (not shown) may be used to make theseconnections.

The control system 130 is configured to be programmed by a patient,healthcare personnel, the patient, etc. In one embodiment, the controlsystem 130 can be programmed on a patient-specific basis to manage andmitigate pressure on one or more existing pressure injuries that arecurrently present on a patient in a specific anatomic location. As thegeometry of the design is specific to the patient's anatomy, thelocation of the pressure injuries on the patient can be entered into thecomputer controlled pump and the ideal pressure time cycle optimized forhealing the pressure injury in that specified anatomic location. Forexample, if a patient has a pressure injury in the typical location overthe sacral bone centrally, the cycle will preferentially drop thepressures in this location and shorten the duration of pressuredelivered to this location in order to promote healing of the pressureinjury. Similarly, if the pressure injury is located over a specificischial tuberosity, right or left, the pressure can be preferentiallyrelieved in this location as the independently pressurized chambers arespecifically designed to fit the underlying anatomy and each region ofconcern is able to be controlled specifically.

In one embodiment, the multi-channel tubing 135 comprises multi-lumentubing to control pressure at different chambers of the plurality ofindependently pressurized chambers. Multi Lumen tubing has multiplechannels running through its profile. Multi Lumen tubing has a variableOuter Diameter (OD), numerous custom Inner Diameters (ID's), and variouswall thicknesses. The tubing can be in a number shapes; circular, oval,triangular, square, crescent, etc.

In one embodiment, the control system 130 may comprise acomputer-controlled multi-channel air pump. The control system 130 mayhave a number of programmable settings and memory to rememberpreferences. For example, the control system 130 may regulate thepressure beneath one or more specific anatomic location(s) based on theweight of the patient 110, which may be programmed by an individual(e.g., the patient 110 or a medical professional) via an interfacegenerated by the control system 130. Further, in some embodiments, thecontrol system 130 can control pressure beneath one or more specificanatomic location(s) for specified durations in order to maximize bloodflow and reduce pressure. The specified durations can be programmable.For example, the control system 130 can control the pressure in each ofthe individual pressurized relief chambers of the pressure mitigationsupport apparatus 120 such that the pressure in any chamber changes oris modified after a specified period of time. In this way, no part ofthe patient's body is left in contact with the pressure mitigationsupport apparatus 120 for more than a period of time. The period of timeis programmable and may be based on pre-programmed settings orcustomizable by the patient and/or a health care professional.

Unlike some alternating pressure support surfaces, the adjustable sidewalls 125 fix the relationship between the patient and the pressuremitigation support apparatus 120. As a result, the pressure mitigationsupport apparatus 120 can reliably reduce pressure in a concerted orconsistent fashion for any specific region of the patient's body injeopardy of developing a pressure injury because the patient is not freeto move about over the pressure mitigation support apparatus 120.Further, unlike products with side support surfaces such as, forexample, supports to keep patients from falling off a large overlaysupport surface (i.e., a mattress overlay) or the supports on a typicalhospital bed, the side supports 125 are customizable to the patient. Forexample, the side walls 125 may be inflatable (pressurized) to fit tothe patient and keep the patient in the correct position (i.e., keep theanatomic region of the patient's body oriented over an epicenter of thegeometric pattern). The pressure mitigation support apparatus 120presented herein is designed with a geometry that requires the patientbe properly held in position on the surface in order for the design toeffectively mitigate the pressure beneath the patient and maximize bloodflow to the tissues at risk for ulceration.

In one embodiment, the side supports 125 will contact the patient gentlyon the lateral aspect of both hips simultaneously in order to activelyorient the patient in the correct orientation on the surface. Thepressure mitigation support apparatus 120 can be customized specificallyto each individual patient in order to be effective at pressure injuryreduction. As will be appreciated, this design is quite different fromthe support surfaces that utilize side walls as a safety barrier toprevent patients from moving off or falling off the surface support asthe patient is free to move about over these surfaces laterally betweenthe sidewalls that are typically as wide apart as a standard hospitalbed. These current products do not require the person to be in a preciselocation on the surface as opposed to the patient-orienting surfacedescribed here.

Being anatomy (or location) specific beneath the patient, allows theapparatus to evenly distribute and rotate pressure from one knownlocation to another ensuring that no one area is under the damagingeffects of constant pressure for a prolonged period of time that couldlead to cell death from ischemia that leads to tissue breakdown andpressure injury formation. Prior art support surfaces which allow apatient to move freely over the support surface cannot reliably rotatepressure from a specific area to another and therefore are limited intheir ability to prevent pressure injuries as compared to the systemsand apparatuses described herein.

Ideally, patients are positioned head up at 30 degrees in bed to preventaspiration pneumonia and to optimally offload the patient's weight offof the sacrum and ischial tuberosities. This is also the ideal bedposition to ensure optimal function of the apparatuses disclosed herein.However, in the event that a patient is positioned flat in bed at 0degrees as shown is the case of the intubated, anesthetized andhypotensive ICU patient (and as shown in FIG. 1), it will be necessaryto confirm ideal patient position over the device without the benefit ofy-axis orientation control achieved by placing the bed at 30 degreeshead up (discussed in greater detail with reference to FIG. 3).

In one embodiment X- and/or Y-axis orientation control can bealternatively or additionally achieved through the use of a radiofrequency (RF) antenna device. For example, as an additional measure toconfirm patient location over the epicenter of our device, an RF antennacan be incorporated into the pressure-relieving surface. A thin flexibleRFID tag/label may be placed on the patient's sacrum using a biologicdressing material. When in the proper orientation, the RFID tag will bedetected by the antennae and a signal light and sound will confirm thecorrect position without needing to look beneath the patient and inspectcorrect location by direct vision. The indicator signal will display thecorrect direction in which to move the patient should reorientation berequired by the staff to ensure the mobility impaired patient (e.g., apatient that is immobile, bed-bound, etc.) is correctly positioned overthe device to maximize pressure redistribution and pressurerotation/relocation.

FIG. 2 depicts an example pressure mitigation support apparatus 200,according to an embodiment. The pressure mitigation support apparatus200 includes side supports 225 and a pressure-mitigating contact portion222. The pressure-mitigating contact portion 222 includes a plurality ofindependently pressurized relief chambers 227. The independentlypressurized relief chambers 227 are configured in a specific geometricpattern that mitigates contact pressure between a support surface and aspecific anatomic region of the patient's body when the specificanatomic region of the patient's body is oriented over an epicenter ofthe geometric pattern.

As shown in the example of FIG. 2, the epicenter may be a central pointof the pressure mitigation support apparatus, however the epicenter neednot be the central point of the apparatus. For example, the epicentermay not be the central point if the pressure mitigation supportapparatus is not symmetric (or even if it is). In some embodiments, theepicenter is a portion of the device that is specifically designed tomatch up with an epicenter of the specific anatomic region of thepatient's body (e.g., the sacral bone when the specific anatomic regionis the sacral region). In one or more embodiments, the epicenter will bemarked so that a patient and/or a caregiver (e.g., nurse) can easilyidentify the epicenter of the apparatus.

In this example, the pressure mitigation support apparatus 200 includesa plurality of independently pressurized relief chambers 227 that areconfigured in a specific “C-shaped” geometric pattern that effectivelymitigates and/or otherwise relieves contact pressure between a supportsurface and a sacral region of a patient's body when the pressure in theplurality of independently pressured relief chambers 227 is alternated.The anatomy specific “C-shaped” geometric design allows the geometricpattern to properly align with the patient's anatomy resulting insuperior redistribution and relocation of pressure as compared to priorart support surfaces.

The geometric pattern(s) described herein are specifically designed tocoincide with the internal anatomy of the sacral region. For example,the geometric pattern of independently pressurized relief chambers 227conforms to a shape based on the internal anatomy (muscle, bone, vessel)in order to maximize the pressure-relieving properties of the apparatus.As a result, pressure relief can be provided in specific areas of thesacral region that are most prone to pressure injury formation, namelyover the bony prominences—the sacrum and ischial tuberosities. Thepattern of the apparatus is therefore symmetric and non-repeating innature. This is different from prior art support surfaces that typicallyemploy repeating patterns over a large surface area of an entire bedmattress. The functionality of these prior art surfaces does not requireknowledge of the location of a patient. That is, with prior art surfacesthere is no benefit for the patient being in one location versesanother. Accordingly, the prior art surfaces are less effective and lessaccurate than the systems and/or apparatuses disclosed herein.

In the example of FIG. 2, the geometric pattern illustrates two lateralrelief chambers forming “C” shapes facing each other around a centralcircular relief chamber which is the size of the sacral bone andpositioned directly over the sacral bone. The central circular reliefchamber is designed to fit the area of skin just at the top of thegluteal fold that overlies the sacral bony prominence which is the areaat greatest risk for pressure injury formation.

In addition to the ability to directly relieving central pressure, thedevice is designed to intermittently relieve pressure just lateral tothis central area. It is in this lateral region that the blood supply tothe central region is located. The major blood supply via a named arteryto the skin overlying the central sacral area runs in a course from deepwithin the pelvis around the lateral aspect of the sacral bone andtravels to the skin overlying the sacrum centrally. Lateral pressuredirectly beneath the C shape regions which overlies the feeding arterialblood supply to the central sacral region will lead to ulcerationcentrally over the sacral bony prominence. The C shapes are locateddirectly over the superior gluteal arteries, the vascular blood supplyto the skin overlying the sacral bone.

A right and left superior gluteal artery run beneath the right and leftC shapes respectively. By deflating the relief chamber that comprisesthe right C shape while the central air cell and the left C shapedrelief chamber remain inflated, the pressure over the right superiorgluteal artery is relieved and blood flow is optimized through the rightsuperior gluteal artery to skin overlying the central area over thesacral bone. Similarly, pressure can be relieved over the left superiorgluteal artery by performing a similar process with respect to theC-shaped air cell over the left superior gluteal artery. Pressure isrotated from one area to another as a result. The harmful effects ofconstant pressure in one location for a prolonged period of time whichcan lead to pressure injury formation are therefore avoided. These aircells are intertwined so that any individual air cell may be deflatedand the other air cells that remain inflated will support the areadefined by the now un-inflated air cell such that an area of lowpressure is created in the area beneath the un-inflated air cell.

In one embodiment, the specific pressure mitigation support apparatus200 may be a partial body alternating contact pressure mattress overlaydevice as shown and discussed in greater detail with respect to FIG. 3Aand FIG. 3B. The pressure mitigation support apparatus 200 may be thepressure mitigation support apparatus 120 of FIG. 1; althoughalternative configurations are possible.

In the example of FIG. 2, the side supports 225 control the spatialrelationship between the patient and the pressure-mitigating contactportion 222. As discussed, the geometric pattern of thepressure-mitigating contact portion 222 is designed to reduce constantpressure on the patient in the same place. In one embodiment, the sidesupports 225 may not be inflatable but fixed. In one embodiment, sidesupports 225 are disposed on each side of the support surface 200 tosupport patients of variable hip width. Further, in some embodiments,the side supports 225 may be decreasing in width from the outermost wallto the innermost wall. It is appreciated that a geometric pattern isshown for simplicity. The pressure-mitigating contact portion 222 mayinclude a variety of different patterns and/or designs and sizes.Further, it is appreciated that the specific pressure mitigation supportapparatus 200 can be designed to reduce pressure for specific regions orportions of a patient's body and/or for a patient's entire body in someinstances.

A control system such as, for example, the control system 130 of FIG. 1individually controls the pressure in each of the independentlypressurized relief chambers. The pressure and length of time each aircell is at a specific pressure will be determined by an algorithm withinthe software program. In order to maximize the efficacy of the system,the specific pressures and timing cycles that will be utilized arepatient-specific. The specific program (time/pressure cycle) specifiedfor an individual patient may be determined by the specific patient'scharacteristics and/or factors that are entered into the pump controllerprogram. This data is used to call for the optimal program for thatpatient. Possible characteristics and/or factors can include, but arenot limited to, the patient's weight, the type of surface upon which theapparatus or overlay rests (e.g., bed, stretcher, air mattress, etc.),the patient position (flat in bed, bed at 30 degrees, bed at 45 degrees,bed at 90 degrees, sitting in chair, etc.), and/or the location ofpreexisting pressure injuries. These characteristics and/or factors maybe used to determine the pressure for the independently pressurizedrelief chambers over a period of time (e.g., the alternating pressure orthe pressures needed to effectively redistribute and relocate pressurewithin a specific anatomic area).

In one embodiment, real-time (or near real-time) feedback from theindependently pressurized relief chambers will allow the pump to adjustthe pressure within each relief chamber towards the desired set pressurefor each air cell at each phase of the cycle. Each relief chamber may beset to a specific pressure for a specific length of time. The cycles ofeach chamber will be coordinated with respect to all other chamberscreating a coordination of inflations and deflations of the entire groupof pressure relief chambers to maximize pressure redistribution andrelief within the apparatus. It is appreciated that there are a finitenumber of cycle patterns that can achieve the desired result based onthe physical constraints dictated by the human anatomy, the size of thesacral area, and the size that the air cells need to be in order to beeffective at pressure relief yet comfortable and not prone to mal-alignthe long axis of the patient's spine if they are too tall in height.

The physiologic pressure around 32 mmHg is the ideal threshold belowwhich pressure ulceration is less likely to occur. Given this idealpressure target of 32 mmHg, the apparatus includes an ideal size of 2-3inches for the pressure relief chambers in a partial body overlay thatwill create the required wall tension of the surface of these air cellsto effectively redistribute high pressure points without causingmal-alignment of the long axis of the patient's spine. Additionally, insome embodiments, the difference in height between adjacent pressurerelief chambers is not more than 1 inch in vertical height afterinflation so as not to create a surface that is uncomfortable to thepatient.

The ideal internal pressures that are optimal in conjunction with theidentified ideal shapes of the pressure-relieving portion of the deviceor apparatus, namely, given the shape and design of the pressure reliefsurface (or pressure-mitigating contact portion), using pressures withinthe central pressure relief chamber that are on average 10 mmHg higherthan the two lateral pressure relief chambers will produce, includeoptimal redistribution of interface pressure between the patient and thedevice.

In one embodiment, the pressure mitigation support apparatus 200 may beconstructed of various materials. For example, material used inconstruction of the inflatable or patient contact portion of thepressure mitigation support apparatus 200 may be determined by thenature of the contact. If the pressure mitigation support apparatus 200is in direct contact with skin a soft, low sheer, breathable fabric isideal. This fabric will have an impervious lining like, for example,polyurethane, etc. that is air tight and used to create the air tightchambers. The materials may be reusable and sterilizable. Conversely, ifthe pressure mitigation support apparatus 200 is underneath a protectivecover or bed sheet, then the inflatable device can be made of animpervious flexible material like polyurethane. This is ideal for amulti-patient patient as it is easily washable and sterilized.

FIG. 3A and FIG. 3B depict top and side views, respectively, of anexample system 300 for orienting a patient over an anatomy-specificpressure-mitigating support surface 320 on which a patient (not shown)rests, according to an embodiment. In this example, the anatomy-specificpressure-mitigating support surface 320 is used in conjunction with atypical hospital bed 315 (i.e., support surface) to control the spatialrelationship between the patient and the hospital bed. A control system330 alternates pressure in the chambers of the anatomy-specific pressuremitigating support surface 320. The control system 330 may be thecontrol system 130 of FIG. 1, although alternative configurations arepossible.

More specifically, in the examples of FIG. 3A and FIG. 3B the supportdevice 320 is placed on or otherwise secured to a standard hospital bed315 that can maintain a 30 degree incline position. The epicenter of thedevice 328 is aligned over the break in the bed so that when a patientis seated on the device the side supports 325 keep the person centeredlaterally (e.g., along the x-axis or from side to side). In thisconfiguration, the bed is in a 30 degree “V” shape position that willkeep the person from moving toward the head or foot of the bed. Thiscreates a centering of the patient over the surface in both theeast-west (between the side walls) and north-south (between the head andleg elevations) directions.

The epicenter 328 of the pressure relieving surface of the apparatus isdesigned to contact the sacrum of the patient at the top of the glutealfold. This is the area of greatest incidence of pressure injuries in bedbound individuals. The apparatus is specifically and uniquely shaped toprotect this portion of the patient anatomy as it represents the centerof the pressure relief surface around which the design is constructed.Conversely, as previously discussed, the repeating patterns of prior artsurface designs at are not anatomy specific. The epicenter 328 isdesigned to be placed and fixed on a support surface (e.g., hospitalbed) such that the epicenter 328 is located and/or otherwise orientedover the break (or “V”) in the bed.

In one embodiment, the epicenter 328 of the apparatus is readilyidentified by its visual characteristics and marked by a central 0.5inch weld at the very center of the pattern. This central half inchcircle is visually aligned with the joint in the bed frame that acts asthe hinge point for flexing or breaking of the bed into the 30 degreeposition.

In one example of installation on bed, the bed is first inspected forthe joint or pivot point. The overlay device or apparatus is then placedon the bed so that the central point or 0.5 inch circular weld withinthe central 4×4 inch relief chamber at the epicenter 328 of the overlayis directly over this joint or hinge point in the bed. Lastly, theoverlay is attached to the bed frame at all four corners of the overlayusing the one or more straps 326. In one embodiment, the straps 326 maybe 1 inch Velcro straps; however any straps that can hold overlay to thebed can be used. The overlay can be placed directly on the mattress andcovered by a fitted sheet or it can be attached to the bed over thefitted sheet. A protective sleeve can be places over the overlay toprotect it and reduce cleaning requirements.

Once a patient is placed on the bed over the overlay device orapparatus, the patient is in a location known to or actively oriented bythe device or apparatus and the control system can then inflate(pressurize) and deflate (depressurize) the pressure relief chambers ofthe relieving portion of the overlay in a preprogrammed cycle forspecific time/pressure values to optimize the pressure-relievingcapabilities of the system. The pressure and timing cycles are alsounique and specific to the design of the system. The pressure and timingcycles may take into account the weight of the patient, the position ofthe bed, and/or the type of surface on which the overlay is resting,etc. The pressures used by the control system may be calculated to bethe minimal pressures needed to achieve even redistribution of highpressure. Interface pressure may be determined by the patient's weightand body position. The greater the weight, the greater the downwardpressure of the patient on the overlay, and thus the greater theinternal pressure will need to be in order to lift the patient off theunderlying mattress in order to affect the redistribution of pressurefrom high points to low points. This data may be programmed into thecontroller by the healthcare team prior to use and is specific for eachpatient.

In one embodiment, the surface area of the pressure-mitigating contactportion 322 (e.g., or pressure relief surface) of the pressuremitigation support apparatus 320 is designed to match the size of thepatient's anatomy in the region of contact made between the patient'ssacral region and the apparatus. Thus, the size of thepressure-mitigating contact portion 322 is the size of the patient'ssurface anatomy between the patient's lower back to the mid-thigh region(i.e., the sacral region). The sacral region is typically a 20×20 squareinch area for the standard adult male of 75 Kg. In some embodiments, thepressure mitigation support apparatus 320 may be size matched to thepatient. For example, the pressure mitigation support apparatus 320 maycome in various sizes such as small, medium, large, extra-large, etc.The sizes may thus range from a 12×12 square inch area to a 35×35 (orgreater) square inch area.

The pressure-mitigating contact portion 322 is also patient sizespecific and designed to mirror the size of the patient. Thus, thedevice or apparatus can have several sizes depending on the patient'sanatomy (e.g., small, medium, large, extra-large, etc.). The device orapparatus is designed so that when sized appropriately, the sidesupports 325 will gently contact the hips of the patient on each sidetherefore aligning the patient over the device such that the patient'sanatomy is aligned with the apparatus design which was patterned on thehuman anatomy.

In one embodiment, ideal patterns include designs that when any givenpressure relief chamber is deflated, the pressure relief chambers thatremain inflated are still effective in comfortably supporting the weightof the patient such that a low pressure area is created and maintainedin the area of the deflated relief chamber region by effectively holdingup the patient in the regions where the relief chambers remain inflated.This means that the relief chambers must be neither too large nor toosmall in any given area or region. In one embodiment, each of the threerelief chambers represent around 33% of the total surface area devicewithin a 20×20 square inch area of the sacral region.

With typical support surfaces (e.g., standard hospital bed) a standardmattress or support surface is 36 inches wide. Accordingly, patientsusing these devices still have ample room between the patient and a sidesupport (or bolster) which allows them to move side to side (laterally).As a result with typical or current support surfaces a patient is notheld in a specific location, and thus the typical support surface cannotbe anatomy specific.

For a device that is specifically designed to function optimally whenlocated beneath the patient's anatomy in a specific location, then theability to move around freely over the surface would render that supportsurface ineffective as the patient and the anatomy specific patternwould not be controlled by the addition of the side bolsters. Thisdiffers from other full mattress overlays or mattress support surfacesthat are not sized to matched in size to the contact surface of thepatient's anatomy but are much larger—i.e. standard bed size of 72inches×36 inches. Most adult patients (ave 75 kg) unless extremely obeseare on average 20 inches wide.

In one embodiment, the pressure relief surface is also contoured to fitthe patient's surface topography in the sacral region (i.e., larger inheight to the lateral aspects of the relief surface and shorter inheight to the center of the pressure relief surface). This contourcreates a bowl shape from side to side in the region of the pressurerelief surface that compliments the human topography of the sacralregion. This is in distinction to the consideration of the internalanatomy, namely blood vessels, muscle and bony anatomy. This internalanatomy is considered in the pattern (not height) of the air cell designwhich is distinct from considerations of surface topography that dictatethe vertical height of the inflated air cells to accommodate variationin the surface contours of the human anatomy. Inflation of the apparatuscan result in a bowl shape.

The bowl shape is designed to create an even distribution of pressurewhen all the air cells of the pressure relief surface are inflated. Theresult of the bowl shape is to maximally redistribute pressure away fromthe central area where pressure injury is most common—namely at the topof the gluteal fold. The pressure is displaced to a more laterallocation towards the hips. The 3-D nature or differences in verticalheight throughout the inflated pressure relief surface is not utilizedin prior art designs. Further, the diameter or vertical height of theinflated pressure relief chambers that make up the pressure reliefsurface are specifically designed to be of a suitable height so as notto be so large as to create mal-alignment of the long axis (spine) ofthe patient but also not of a height that would be to small as to beineffective as a pressure relief surface. This vertical height isroughly 2-3 inches on average.

FIG. 4A and FIG. 4B depict top and cross-sectional views, respectively,of an example pressure mitigation support apparatus 400, according to anembodiment. The pressure mitigation support apparatus 400 includes sidesupports 425 and a pressure-mitigating contact portion 422. Thepressure-mitigating contact portion 422 includes a plurality ofindependently pressurized relief chambers 427. The independentlypressurized relief chambers 427 are configured in a specific geometricpattern that effectively mitigates contact pressure between a supportsurface and a specific anatomic region of the patient's body when thespecific anatomic region of the patient's body is oriented over anepicenter of the geometric pattern. The pressure mitigation supportapparatus 400 may be, for example, the pressure mitigation supportapparatus 120 of FIG. 1; although alternative configurations arepossible.

As discussed above, the pressure mitigation support apparatus 400includes channel tubing 436. The channel tubing 436 is separate from thepressure relief surface portion of the device but can be incorporatedinto the design of the device such that the tubing will follow the seamsor channels between the pressure relief surfaces where adjacentindependently pressurized relief chambers meet. In one embodiment, thechannel(s) are recessed into the seams when the relief chambers 427 arepressurized and/or otherwise inflated. Thus, once the relief chambers427 are pressurized and/or otherwise inflated, the channel tubing 436does not make physical contact with the patient. Additionally, thechannel tubing 436 does not contribute to the pressure mitigationfunction of the device or apparatus. That is, the channel tubing 436serves only to circulate pressure (e.g., air, liquid, etc.) between theseams or recessed channels created by the relief chambers 427.

In one embodiment, the pressure that exits the channels does notoriginate from the relief chambers of the pressure relief surfaces. Forexample, the pressure that exits from the multi-channel tubing canoriginate from its own separate source. The pressure or flow from thepressure channels is controlled by a control system such as, forexample, the control system 130 of FIG. 1. The control system cancontrol the pressure (e.g., the air supply) and not by the internalpressure of an air-filled bladder that comprises a portion of a pressurerelieving surface as is the case when a device is configured as a lowair loss surface.

The channel tubing 436 is designed as a passive conduit and not aschamber designed to inflate. The channel tubing 436 may be designed notfor low air loss as is the case with previously described low air losssurfaces that leak a low amount of air from the internal reservoir ofthe inflated support surface, but the air channels described heredeliver do not leak a high volume of air or gas dedicated only to thispurpose and none other. The rate of air flow from the channels isprecisely controlled by a flow meter and not dependent on internalpressures created within the device as is the case with the low air lowsurfaces. The channels may have one or more openings for the release ofair. The control of the volume of air delivered and not “lost” from thesurface is under strict control for the device as is not the case of lowair loss surfaces. (Volume not pressure control). In a low air losssetting, if the openings are blocked by the weight of the patient, theair which is at the set pressure of the pressure relieving air chamberwill stop flowing. This is different for the air channels described herewhere the air is delivered by volume control. If the openings to deliverthe air are blocked by the weight of the patient, the pressure of thedelivered air will continue to rise until it is greater than theexternal force blocking the openings of the air channels. This variablepressure is not possible in a low air loss configuration. Volume controldelivery in a low air loss setting would also control the pressurewithin the air chamber of the support surface which is undesirable.

FIG. 5 depicts an example pressure mitigation support apparatus 500,according to an embodiment. The pressure mitigation support apparatus500 includes a pressure-mitigating contact portion 222 and one or moreadhesive portions 545. The pressure-mitigating contact portion 222includes a plurality of independently pressurized relief chambers 527.In this example, the independently pressurized relief chambers 527 areconfigured in a specific geometric “C-shape” pattern that mitigatescontact pressure between a support surface and a specific anatomicregion of the patient's body when the specific anatomic region of thepatient's body is oriented over an epicenter of the geometric pattern.The one or more adhesive portions are interconnected on the mitigationsupport apparatus 500. The adhesive portion may be configured toactively orient the specific anatomic region of the patient's body overthe epicenter 528 of the geometric pattern through one or morebiocompatible adhesives. Although the pressure mitigation supportapparatus 500 is shown without side supports, it is appreciated thatsuch supports may be included in some embodiments.

In the example, of FIG. 5, the one or more adhesive portions 545 areshown with cross shading. The one or more adhesive portions 545 may bebiocompatible adhesive portions that extend along a section of theperimeter of the contact pressure-mitigation support apparatus.Alternatively or additionally, the one or more adhesive portions 545 mayextend along at least a section of one or more of the plurality of theindependently pressurized relief chambers such as, for example, the“C-shaped” independently pressurized relief chambers.

In one embodiment, the one or more adhesive portions 545 can be adhereddirectly to the area of concern via a biocompatible adhesive such as,for example, the adhesive material used in common medical band-aids. Inthis case, the pressure mitigation support apparatus 500 may essentiallyact as an inflatable band-aid “like” device that could be in the form ofthe two “C-shapes” around a central area of ulceration or a central areaat risk of ulceration.

FIG. 6 depicts a flow chart illustrating an example process 600 forcoordinated chamber inflation and deflation of a therapeutic surface tostimulate blood flow and reduce pressure while a spatial relationshipbetween a patient and a therapeutic surface is controlled by side-wallsof the therapeutic surface.

As discussed, the inflatable support surface is comprised of the twoside walls and a center portion with multiple separate air bladders (orchambers) designed in a specific pattern to best preserve blood flow andreduce pressure when inflated and deflated in a coordinate fashion thatis controlled by settings in the air pump control device. Process 600describes the coordinated chamber inflation and deflation of atherapeutic surface according to one embodiment.

In step 610, an air pump control system such as, for example, air pumpcontrol system 130 of FIG. 1 determines an initial pressure for each ofa plurality of independently pressurized chambers built into atherapeutic support surface. In step 612, the air pump control systeminitializes one of more of the settings. The initialization of thesetting can include selecting a program and/or one or more pressuretimers. The pressure timers can control when and if to change thepressure at an individual chamber. In one embodiment, each chamber hasits own timer. However, in other embodiments, some chambers may sharetimers. Further, any of the chamber timers can be configured to work inconcert. In one embodiment, one or more of the initialization settingscan be based on the patient (e.g., weight, age, pre-programmed, etc.).In step 614, the air pump control system checks to see if a timer hasexpired, and if so, in step 616, the air pump control system adjusts thepressure in the associated chamber accordingly.

FIG. 7 depicts a schematic diagram illustrating an example pressuremitigation support apparatus 700, according to an embodiment. Thepressure mitigation support apparatus 700 includes side supports 725 anda pressure-mitigating contact portion 422. The pressure-mitigatingcontact portion 722 includes a plurality of independently pressurizedrelief chambers 727. The pressure mitigation support apparatus 700 maybe, for example, the pressure mitigation support apparatus 120 of FIG.1; although alternative configurations are possible.

In one embodiment, the independently pressurized relief chambers 727 areconfigured in a specific geometric pattern that effectively mitigatescontact pressure between a support surface and a specific anatomicregion of the patient's body when the specific anatomic region of thepatient's body is oriented over an epicenter of the geometric pattern.For example, in the example of FIG. 7, three independently pressurizedrelief chambers 727 are shown: M-shaped relief chamber 727 a, leftc-shaped relief chamber 727 b, and right c-shaped relief chamber 728 c.These relief chamber receive pressure or air from corresponding inlets721.

In one embodiment, the geometric pattern includes the firstindependently pressurized relief chamber 727 a which intersects theepicenter of the geographic pattern, and second and third independentlypressurized relief chambers, 727 b and 727 c, respectively, thatcollectively encompass the first independently pressurized reliefchamber. More specifically, in the example of FIG. 7, the firstindependently pressurized relief chamber 727 a generally comprises anM-shape with the epicenter of the geometric pattern residing at theinternal angle formed by the intersecting planes of the M-shape, and thesecond independently pressurized relief chamber 727 b generallycomprises a C-shape that encompasses a left-most bisection of the firstindependently pressurized relief chamber, and the third chamber 727 ccomprises a symmetric mirror image of the second chamber about thebisection of the first chamber.

FIG. 8 depicts a side view of an example system 800 for orienting apatient over an anatomy-specific pressure-mitigating contact surfacewith lower extremity wedge on which the patient rests, according to anembodiment. The example of FIG. 8 is similar to the example of FIG. 1,however the pressure mitigation support apparatus 820 includes a lowerextremity wedge 840 and an optional wedge wrap 850.

In one embodiment, the lower extremity wedge 840 is an inflatable wedgethat is designed to fit (or sit) beneath the lower extremities of theuser. The lower extremity wedge 840 can elevate the legs to provideadditional benefits to a patient or user. In one embodiment, the lowerextremity wedge 840 can be attached to or be part of (integrated into orwith) the side supports 825.

In one embodiment, the lower extremity wedge 840 can prevent themigration of the user toward the foot of the bed (lengthwise movement)and/or can act to further maintain the position of the user over thepressure mitigation support (PMS) apparatus 820 in the Y-axis.

As discussed above, in one embodiment, the pressure mitigation supportapparatus can comprise an overlay that can be extended behind apatient's lower extremities to include a wedge 840 configured to elevatethe legs in order to prevent the user from moving toward the foot of thebed. Accordingly, the wedge 840 aids in the control of the user'slocation over the pressure mitigation support apparatus. As the side airbolsters (side supports 825) orient the user's location over thepressure mitigation support apparatus so too does the wedge 840 behindthe lower extremities by preventing the user from moving toward the footof the bed when the head of the bed is elevated. In one embodiment, thewedge 840 lifts the lower extremities when in use and protects theuser's heals.

In one embodiment, the pressure mitigation support apparatus 820 (or thewedge 840) includes a wedge wrap 850. The wedge wrap 850 can beconfigured to wrap around the lower extremities to serve both as a deepvenous thrombosis prevention device and a pressure ulcer preventiondevice. Accordingly, in operation, the wedge 840 can lift the lowerextremities (e.g., a user's or patient's heels) from the support surface115 leaving the heels less prone to the formation of pressure ulcers.

In one embodiment, all or part of the wedge 840 can be removablydetachable from the pressure relieving portion (i.e., the pressuremigration support apparatus 820) or it may be constructed as one unit.

FIG. 9 is a partially schematic top view of a pressure-mitigationapparatus 900 (also referred to as a “pressure-mitigation device” or a“pressure-mitigation pad”) illustrating varied pressure distributionsfor avoiding localized ischemia and resulting reperfusion injury for amobility impaired patient (e.g., immobilized and/or bed-ridden patients)in accordance with embodiments of the present technology. As discussedabove, when a human body is supported by a contact surface 902 for anextended duration, pressure injuries may form over bony prominences suchas the skin overlying the sacrum, coccyx, heels, or hips. These bonyprominences often represent the location or locations at which the mostpressure is applied by the contact surface 902 and, therefore, may bereferred as the “main pressure point(s)” along the surface of the humanbody. To prevent the formation of pressure injuries, healthy individualsperiodically make minor positional adjustments (also known as“micro-adjustments”) to shift the location of the main pressure point.However, individuals having impaired mobility often cannot make thesemicro-adjustments by themselves. Mobility impairment may be due tophysical injury (e.g., a traumatic injury or a progressive injury),movement limitations (e.g., within a vehicle, on an aircraft, or inrestraints), medical procedures (e.g., those requiring anesthesia),and/or other conditions that limit an individual's natural movement. Forthese mobility impaired individuals, the pressure-mitigation apparatus900 can be used to shift the location of the main pressure point(s) ontheir behalf. That is, the pressure mitigation apparatus 900 createsmoving pressure gradients to avoid sustained, localized vascularcompression and enhance tissue perfusion.

As shown in FIG. 9, the pressure-mitigation apparatus 900 can include aseries of chambers 904 (also referred to as “cells”) whose pressure canbe individually varied. The chambers 904 may be formed byinterconnections between a first or top layer and a second or bottomlayer of the pressure-mitigation apparatus 900. The top layer may becomprised of a first material (e.g., an air-permeable, non-irritatingmaterial) configured for direct contact with a human body, while thebottom layer may be configured of a second material (e.g., anon-air-permeable, gripping material) configured for direct contact withthe contact surface 902 on which the pressure-mitigation apparatus 900is placed. In these and other embodiments, the top layer and/or thebottom layer can be comprised of more than one material, such as acoated fabric or a stack of interconnected materials.

A pump, such as the pressure device 132 described above with respect toFIG. 8, can be connected to each chamber 904 (e.g., via a correspondinginlet valve), and controllably vary the pressure in each chamber 904 onan individual basis in accordance with a predetermined pattern. Asfurther described below, the pump and associated controller can operatethe series of chambers 904 in several different ways. In someembodiments, the chambers 904 have a naturally deflated state, and thepump can be programmed to inflate at least one of the chambers 904 toshift the main pressure point along the anatomy of the user. Forexample, the pump may be programmed to inflate at least one of thechambers 904 located directly beneath an anatomical region tomomentarily apply contact pressure to that anatomical region and relievethe contact pressure on the surrounding anatomical regions adjacent tothe deflated chambers 904. In these and other implementations, the pumpmay be programmed to inflate two or more chambers 904 adjacent to ananatomical region to create an open space or void beneath the anatomicalregion to shift the main pressure point at least momentarily away fromthe anatomical region. In other embodiments, the chambers 904 have anaturally inflated state, and the pump can be programmed to deflate atleast one of the chambers 904 to shift the main pressure point along theanatomy of the user. For example, the pump may be configured to deflateat least one of the chambers 904 located directly beneath an anatomicalregion, thereby forming a void beneath the anatomical region tomomentarily relieve the contact pressure on the anatomical region.Whether configured in a naturally deflated or naturally inflated state,the continuous or intermittent alteration of the inflation levels of theindividual chambers 904 moves the location of the main pressure pointacross different portions of the human body. As shown in FIG. 9, forexample, inflating and/or deflating the chambers 904 creates temporarycontact regions 906 that move across the pressure-mitigation apparatus900 in a predetermined pattern, and thereby changing the location of themain pressure point(s) on the human body for finite intervals of time.Thus, the pressure-mitigation apparatus 900 can simulate themicro-adjustments made by mobile individuals to relieve stagnantpressure application caused by the contact surface 902.

As noted above, the series of chambers 904 may be arranged in ananatomy-specific pattern so that when the pressure within one or moreindividual chambers is altered, the contact pressure on a specificanatomical region of the patient is relieved (e.g., by shifting the mainpressure point elsewhere). As shown in FIG. 9, for example, the mainpressure point can be moved between eight different locationscorresponding to the eight temporary contact regions 906. In someembodiments the main pressure point shifts between these locations in apredictable manner (e.g., in a clockwise or counter-clockwise pattern),while in other embodiments the main pressure point shifts between theselocations in an unpredictable manner (e.g., in accordance with a randompattern, a semi-random pattern, and/or detected pressure levels). Thoseskilled in the art will recognize that the quantity and position ofthese temporary contact regions 906 may vary based on the arrangement ofthe series of chambers 904, the anatomical region supported by thepressure-mitigation apparatus 900, the characteristics of the human bodysupported by the pressure mitigation apparatus 900, and/or the conditionof the user (e.g., completely immobilized, partially immobilized, etc.).

In some embodiments, the pressure-mitigation apparatus 900 does notinclude side supports because the patient's condition may not benefitfrom the positioning provided by the side supports. For example, sidesupports can be omitted when the patient is medically immobilized (e.g.,under anesthesia, in a medically induced coma, etc.) and/or physicallyrestrained by the underlying support surface (e.g., rails along the sideof a bed, arm rests on the side of a chair) and/or other structures(e.g., physically restraints holding down the patient, casts, etc.).

FIG. 10A is a partially schematic side view of a pressure-mitigationapparatus 1002 a for relieving pressure on a specific anatomical regionby chamber deflation in accordance with embodiments of the presenttechnology. The pressure-mitigation apparatus 1002 a is positionedbetween a contact surface 1000 (e.g., a bed, table, or chair) and ahuman body 1004 and, to relieve pressure on a specific anatomical regionof the human body 1004, at least one chamber 1008 a of a plurality ofchambers (referred to collectively as “chambers 1008”) proximate to thespecific anatomical region at least partially deflates to create an openspace or void 1006 a beneath the specific anatomical region. In suchembodiments, the remaining chambers 1008 may remain inflated. Thus, thepressure-mitigation apparatus 1002 a may sequentially deflate chambers1008 (or arrangements of multiple chambers) to relieve the contactpressure applied to the human body 1004 by the contact surface 1000.

FIG. 10B is a partially schematic side view of a pressure-mitigationapparatus 1002 b for relieving pressure on a specific anatomical bychamber inflation in accordance with embodiments of the presenttechnology. For example, to relieve pressure at a specific anatomicalregion of the human body 1004, the pressure-mitigation apparatus 1002 bcan inflate two chambers 1008 b and 1008 c disposed directly adjacent tothe specific anatomical region to create a void 1006 b beneath thespecific anatomical region. In such embodiments, the remaining chambersmay remain at least partially deflated. Thus, the pressure-mitigationapparatus 1002 b may sequentially inflate a chamber (or arrangements ofmultiple chambers) to relieve the contact pressure applied to the humanbody 1004 by the contact surface 1000.

In some embodiments, the pressure-mitigation apparatuses 1002 a and 1002b of FIGS. 10A and 10B can have the same configuration of chambers 1008,and can operate in both a normally inflated state (described withrespect to FIG. 10A) a normally deflated state (described with respectto FIG. 10B) based on the selection of the operator (e.g., a medicalprofessional or the user). For example, the operator can use acontroller to select a normally deflated mode such that thepressure-mitigation device operates as described with respect to FIG.10A, and then change the mode of operation to a normally inflated modesuch that the pressure-mitigation device operates as described withrespect to FIG. 10B. Thus, the pressure-mitigation apparatuses disclosedherein can shift the location of the main pressure point by controllablyinflating the chambers, controllably deflating the chambers, or acombination thereof.

FIG. 11 is a flow diagram of a process 1100 for treating a conditionusing a pressure-mitigation apparatus in accordance with embodiments ofthe present technology. In step 1102, a medical professional diagnoses ahigh-risk, perfusion-challenged, mobility-impaired patient, whose statecan be improved by increased blood flow and a decreased presence ofproinflammatory mediators. For example, such patients may include thosesubject to a condition that causes prolonged sedentary or immobileperiods. Examples of conditions that may be improved by increased bloodflow and a decreased presence of proinflammatory mediators includeburns, trauma, pressure injury, ischemia, strokes, Parkinson's disease,and/or various other diseases or injuries. These conditions areimproved, at least in part, by reducing the likelihood of or preventingischemia and reperfusion injury and, thereby, inhibiting or preventingthe release of proinflammatory mediators.

In step 1104, the medical professional determines an appropriatetreatment regimen for the condition. For example, if the condition is apressure ulcer, the medical professional may determine the appropriateconventional treatment regimen should include reducing pressure on thecorresponding anatomical region (e.g., by repositioning the patient),cleaning/dressing the wound, and/or excisional debridement of necroticand/or infected tissue. As another example, if the condition is astroke, the medical professional may determine the appropriate treatmentregimen should include therapy with clot-busting drugs (e.g., a tissueplasminogen activator), treatment with endovascular procedures (e.g.,insertion of a catheter or a stent), and/or other conventionalstroke-related treatments. As another example, if the condition isischemia, the medical professional may determine the appropriateconventional treatment regimen should include administration of amedication (e.g., aspirin, nitrates, beta blockers, calcium channelblockers, cholesterol-lowering medications, angiotensin-convertingenzyme (ACE) inhibitors, or ranolazine), angioplasty/stenting, coronaryartery bypass surgery, enhanced external counterpulsation, and/or otherconventional ischemia-related therapies.

To enhance or expedite the treatment of the diagnosed conditions, themedical professional or someone else associated with the treatmentprotocol may choose to augment the normal treatment regimen byincorporating the use of a pressure-mitigation apparatus (e.g., thepressure-mitigation apparatuses described with respect to FIGS. 10A-10Babove). The pressure-mitigation apparatus can be placed between thepatient and a contact surface, such as a patient bed, a surgical table,and/or other surface used to support the patient, and activated to shiftthe main pressure point of the contact pressure across different regionson the surface of the patient's body, thereby enhancing blood flowbetween the patient's body and the contact surface (step 1106). To shiftthe main pressure point of the contact pressure, a series of chambers ofthe pressure-mitigation apparatus can be controllably inflated,deflated, or any combination thereof (e.g., as described with respect tothe pressure-mitigation apparatuses of FIGS. 10A-10B). The series ofchambers can be generally arranged in an anatomy-specific pattern.Consequently, the series of chambers may be inflated/deflated in such amanner to improve blood flow around the anatomical region for which thepressure-mitigation apparatus is designed. Thus, the pressure-mitigationapparatus may include different arrangements of chambers depending onwhether it is designed to improve blood flow to the sacral region,lumbar region, thoracic region, and/or other anatomical region of thebody. While embodiments may be described in the context of improvingblood flow to the dorsal side of a human body, those skilled in the artwill recognize that pressure-mitigation apparatuses may be designed toimprove blood flow to other sites (e.g., the ventral side of the body,the elbows, knees, ankles, shoulders, or cranium) as well.

In step 1108, treatment of the condition can continue in accordance withthe treatment regimen prescribed for the condition. However, severalbenefits are expected result due to the increased blood flow resultingfrom deployment of the pressure-mitigation apparatus and associatedsystem. In some instances, the overall treatment of the patient mayrequire less equipment than would otherwise be necessary. For instance,deployment of the pressure-mitigation apparatus may allow for the use ofstandard hospital beds, and lessen or eliminate the need for certainexpensive, space-consuming equipment therapy beds, therapeutic/pressurerelief cushions, pressure redistribution overlays, and/or heeloffloading devices. The use of the pressure-mitigation system can alsoreduce the amount of manual care (e.g., from nurses, doctors, etc.) thanwould otherwise be necessary to manually shift the location of the mainpressure point along the dorsal side of a patient (e.g., by turning thepatient) during periodic time intervals. In addition, it is expectedthat the incorporation of pressure-mitigation systems can reduce theoverall use of medication because the system may reduce or prevent thegeneration of inflammatory mediators, which increase pain, inflammation,and exacerbate certain conditions. Accordingly, less medication (e.g.,pain relievers) may be needed to treat the secondary conditions thattypically occur from long periods of immobilization. Furthermore, theincorporation of pressure-mitigation systems inhibits or preventsischemia and reperfusion injury and, therefore, is expected to lead toshorter overall hospital stays (also referred to as “length of stay” or“LOS”). More specifically, by inhibiting or preventing ischemia andreperfusion injury, the pressure-mitigation system reduces theproduction of excess proinflammatory mediators that can eventuallycirculate through the blood stream. With less proinflammatory mediators,the pressure-mitigation system reduces systemic inflammation andprevents these mediators from circulating to other areas of the body(e.g., the brain) where they can cause localized inflammation, increasedamage, and/or worsen other conditions. Moreover, pressure-mitigationapparatuses can be readily deployed in non-hospital settings (e.g., in apatient's home) to allow treatment to continue in non-hospital settings.

Selected Clinical Examples Exhibiting Impact of Improved Blood Flow

Several different studies have been performed to illustrate the effectsof deploying pressure-mitigation apparatuses, such as the pressuremitigation apparatuses and systems described above, to enhance perfusionfor treatment of sacral region injuries (e.g., pressure ulcers) andother ischial pressure injuries. These studies will be discussed ingreater depth below.

A clinical study was performed to compare the time it took to fully healpatients with stage 2 pressure injuries managed with pressure-mitigationapparatuses with the time it took to fully heal a size-matched cohort ofpatients with stage 2 pressure injuries managed with conventionalalternating-pressure mattresses. The study enrolled 31 patients thatresided in 4 community-based, long-term care facilities.

Patients in the control group were provided with a low-air-loss mattresscapable of alternating pressure in accordance with the correspondingfacility's treatment protocol for stage 2 pressure injuries. Patients inthe experimental group were provided with the pressure-mitigationapparatuses described herein rather than a low-air-loss mattress. Foreach patient in the experimental group, the pressure-mitigationapparatus was installed on top of a standard static-foam mattress or astandard recovery chair. Both groups otherwise received an identicalstandard of care.

The primary outcome measure was the time for complete healing of thestage 2 pressure injuries. Kaplan-Meir and log-rank tests werecalculated to analyze the time-to-heal data, and then generate thecomparison results. Patient characteristics were compared using standardt-tests for data sets and Chi-squared tests for proportions to ensurethat the differences in average values and ratios between the controland experimental groups were not statically significant.

As shown in Table I, 9 patients in the experimental group with 14 stage2 pressure injuries completed the trial, and 22 patients in the controlgroup with 28 stage 2 pressure injuries were identified for comparisonpurposes. Various characteristics of these patients are provided inTable II.

TABLE I Summary of trial participants. Control Group Experimental GroupTotal Patients Enrolled 22 10 32 Patients Withdrawn 0 1 1 PatientsCompleting Trial 22 9 31 Number of Pressure Injuries 28 14 42

TABLE II Characteristics of trial participants. Statistically ControlExperimental Significant Group Group P-Value Difference? Mean Age(Years) 82 84.86 0.46 No Mean Pressure 1.8 1.5 0.64 No Injury Size (cm²)Mean Braden Scale 16.04 15.50 0.61 No Male Patient Percent 45.5% 11.11% 0.07 No Wheelchair Use Percent 86.36% 100% 0.25 No Incontinent Percent77.27 66.67 0.55 No

The mean time to fully heal the pressure injuries for the control groupwas 26.25 days with a standard deviation of 2.42 days and upper/lower95% confidence boundaries of 21.51 days and 30.99 days, respectively. Incontrast, the mean time to fully heal the pressure injuries for theexperimental group was 10.50 days with a standard deviation of 1.02 daysand upper/lower 95% confidence boundaries of 8.51 days and 12.49 days,respectively. Thus, the mean time to fully heal for the experimentalgroup was roughly 40% of the mean time to fully heal for the controlgroup. Over the course of the study, patients in the control group tookroughly 150% longer to fully heal from their stage 2 pressure injuriesthan those patients who were treated with the pressure-mitigationapparatuses described herein. Accordingly, the pressure-mitigationsystems disclosed herein have been shown to significantly decrease theoverall healing time of pressure injuries in comparison to low-air-lossalternating pressure mattresses.

In a patient study, a pressure-mitigation system as disclosed herein wasshown to expedite the healing of a stage 3 pressure injury. An81-year-old male patient sustained three ischemic strokes, waseventually discharged on hospice care, and, within a week of being home,the patient developed a stage 3 pressure injury despite being turned bymedical staff every two hours and also caused additional distress andpain. The wound was initially treated with collagenase-based ointmentand intermittent use of foam dressings. Additional nursing staff wasalso hired to provide more frequent turning.

The treatment regime was modified to supplement the incremental turningof the patient with a pressure-mitigation apparatus affixed to thepatient's bed. The pressure-mitigation apparatus was from thereon usedcontinuously, and complete healing of the stage 3 pressure injuryoccurred 52 days following deployment of the pressure-mitigationapparatus. Additional information on the healing trajectory of the stage3 pressure injury are provided in Table III. In addition, afterintroduction of the pressure-mitigation apparatus, the patient indicateda higher level of comfort and requested a substantial reduction in thefrequency of repositioning. Indeed, the speed at healing afterintroduction of the pressure-mitigation apparatus allowed for asignificant decrease in the turn frequency. It is expected that theintroduction of the pressure-mitigation apparatus to the patient'streatment regime significantly reduced overall healing time incomparison to the only using intermittent turning protocols.

TABLE III Healing trajectory of a stage 3 pressure injury. PercentagePercent- Healed age from Healed Initiation from of Vol- Pre- Pressure-Length Width Depth ume vious Mitigation (cm) (cm) (cm) (cm³) WeekApparatus October 17 1.0 1.0 0.0 N/A N/A N/A October 24 3.2 2.0 0.1 0.64N/A N/A October 30 3.5 2.0 0.1 0.70 −109% N/A November 6 2.5 2.0 0.10.50 29% 29% November 16 1.5 1.5 0.1 0.23 54% 68% November 27 0.5 0.50.0 N/A 100% 96% December 7 0.0 0.0 0.0 N/A 100% 100%

In another patient study, a pressure-mitigation system as disclosedherein was shown to reduce the duration of healing of a stage 4 sacralpressure injury. A 64-year-old male patient sustained a level 4 cervicalspine fracture with incomplete spinal cord injury, paraplegia, andimpaired sensation. After the acute and rehabilitative treatment hadbeen administered, the patient was admitted to a nursing facility forlong-term care. Thereafter, the patient was diagnosed with a stage 4pressure injury, and then treated with sharp surgical debridement andnegative pressure wound therapy (NPWT).

After 132 days, a pressure-mitigation apparatus was introduced to thetreatment regimen. Complete healing of the stage 4 pressure injuryoccurred in 118 days following deployment of the pressure-mitigationapparatus. Additional conversations with the patient suggested that thepressure-mitigation apparatus was also effective in reducing the painassociated with pressure injuries and mobility impairment. Additionalinformation on the healing trajectory of the stage 4 pressure injury areprovided in Table IV. Based on this information, it is expected that theaddition of the pressure-mitigation apparatus to the patient's treatmentregime reduced overall healing time and patient comfort in comparison tothe conventional techniques previously employed.

TABLE IV Healing trajectory of a stage 4 pressure injury. PercentageHealed from Percentage Initiation Healed of from Pressure- Length WidthDepth Volume Previous Mitigation (cm) (cm) (cm) (cm³) Month ApparatusJanuary 2.0 1.3 0.6 1.6 39% N/A February 2.2 1.2 0.5 1.3 19% 19% March1.5 1.0 0.2 0.5 62% 69% April 0.3 0.1 0.2 0.006 99% 99% May 0.0 0.0 0.00.0 100% 100%

Another study was performed to assess pressure injury prevention suingpressure-mitigation systems as disclosed herein. More specifically, thestudy compared the hospital-acquired pressure injury incidence in agroup of patients utilizing the pressure-mitigation systems disclosedherein in conjunction with the standard of care to a control groupreceiving only the standard of care prevention measures (i.e.,intermittent turning of the patient). (Jitendra B. Bharucha et al., AProspective Randomized Clinical Trial of a Novel, Noninvasive PerfusionEnhancement System for the Prevention of Hospital-Acquired SacralPressure Injuries. J. Wound Ostomy Continence Nurs. 310-318 (2018).) Thestudy enrolled 431 patients, and 399 patients completed the study. Inthe experimental group, the majority of the withdrawals were due to thenoise from the pressure-mitigation apparatus or the sensation due to thecontinuous movement beneath the sacral region. Patients in the controlgroup were treated in accordance with a methodology referred to as a“S.K.I.N.” Bundle (S—surface selection, K—keep turning, I—incontinencemanagement, N—nutrition), promulgated by the Ascension Health System.Patients in the experimental group were given the pressure-mitigationapparatuses described herein. Both groups otherwise received anidentical standard of care, and all care measures were documented in anelectronic health record (EHR) system.

As shown in Table V, the characteristics of the control and experimentalgroups were statistically similar with respect to age, Braden Scalescore, and body mass index (BMI). Patients in the study ranged in agefrom 24 to 100 years.

TABLE V Characteristics of trial participants. Experimental ControlGroup Group Total Number of Patients 213 186 Finished TrialHospital-Acquired Pressure 11 2 Injury Incidence Age Range 35-98 24-100Mean Age 74.38 74.69 Mean Braden Scale Score 14.5 14.2 Male Patients 79(37.1%) 94 (50.6%) Mean BMI 27.9 28.3 Mean Length of Stay 9.328 8.667

There were a wide range of discharge diagnoses (i.e., reasons why theindividuals initially received the pressure injuries) for the trialparticipants, although there was no statistical difference betweendischarge diagnoses in the control and experimental groups. The topprimary diagnoses at discharge were sepsis (n=71; 17.8% of all subjectsin the trial), respiratory failure (n=36; 9%), septic shock (n=32; 8%),stroke (n=31; 7%), and acute kidney injury (n=18; 4.5%). Uponcompetition of the study, it was evident that the patients in theexperimental group received clinically significant benefits incomparison to the patients in the control group. For example, elevenpatients (5.16%) in the control group versus two patients (1.07%) in theexperimental group developed hospital-acquired, sacral-region pressureinjuries beyond what these patients already had. The difference betweenpressure injury incidence rates of the control and experimental groupswas statistically significant (P=0.024). The mean length-of-stay (LOS)for all patients in the control group was 9.328 days, while the mean LOSfor all patients in the experimental group was 8.667 days. Thus, theaverage LOS of the experimental group was roughly 0.66 days (7.1%) lessthan the control group, which not a statistically significant difference(P=0.46). However, when the mean LOS was examined by dischargediagnosis, it was discovered that the majority of the reduction in meanLOS seen in the experimental group was concentrated amongst thosepatients with one of two discharge diagnoses: stroke (n=31; 7.8%) andacute kidney injury (n=18; 4.5%). For these patients, the mean LOS inthe experimental group was 5.865 days, and the mean LOS in the controlgroup was 13.747 days. This difference was statistically significant(P=0.045). Accordingly, in this large-scale study, thepressure-mitigation systems have been shown to reduce the likelihood ofhospital-acquired, sacral-region pressure injuries, as well as reducethe mean LOS for stroke and acute kidney injury.

Processing System

FIG. 12 is a block diagram illustrating an example of a processingsystem 1200 in which at least some operations described herein can beimplemented. For example, some components of the processing system 1200may be hosted on a control system (e.g., control system 130 of FIG. 1)responsible for controlling a pressure mitigation support apparatus(e.g., pressure mitigation support apparatus 120 of FIG. 1).

The processing system 1200 may include one or more central processingunits (“processors”) 1202, main memory 1206, non-volatile memory 1210,network adapter 1212 (e.g., network interface), video display 1218,input/output devices 1220, control device 1222 (e.g., keyboard andpointing devices), drive unit 1224 including a storage medium 1226, andsignal generation device 1230 that are communicatively connected to abus 1216. The bus 1216 is illustrated as an abstraction that representsone or more physical buses and/or point-to-point connections that areconnected by appropriate bridges, adapters, or controllers. The bus1216, therefore, can include a system bus, a Peripheral ComponentInterconnect (PCI) bus or PCI-Express bus, a HyperTransport or industrystandard architecture (ISA) bus, a small computer system interface(SCSI) bus, a universal serial bus (USB), IIC (I2C) bus, or an Instituteof Electrical and Electronics Engineers (IEEE) standard 1394 bus (alsoreferred to as “Firewire”).

The processing system 1200 may share a similar computer processorarchitecture as that of a desktop computer, tablet computer, personaldigital assistant (PDA), mobile phone, game console, music player,wearable electronic device (e.g., a watch or fitness tracker),network-connected (“smart”) device (e.g., a television or home assistantdevice), virtual/augmented reality systems (e.g., a head-mounteddisplay), or another electronic device capable of executing a set ofinstructions (sequential or otherwise) that specify action(s) to betaken by the processing system 1200.

While the main memory 1206, non-volatile memory 1210, and storage medium1226 (also called a “machine-readable medium”) are shown to be a singlemedium, the term “machine-readable medium” and “storage medium” shouldbe taken to include a single medium or multiple media (e.g., acentralized/distributed database and/or associated caches and servers)that store one or more sets of instructions 1228. The term“machine-readable medium” and “storage medium” shall also be taken toinclude any medium that is capable of storing, encoding, or carrying aset of instructions for execution by the processing system 1200.

In general, the routines executed to implement the embodiments of thedisclosure may be implemented as part of an operating system or aspecific application, component, program, object, module, or sequence ofinstructions (collectively referred to as “computer programs”). Thecomputer programs typically comprise one or more instructions (e.g.,instructions 1204, 1208, 1228) set at various times in various memoryand storage devices in a computing device. When read and executed by theone or more processors 1202, the instruction(s) cause the processingsystem 1200 to perform operations to execute elements involving thevarious aspects of the disclosure.

Moreover, while embodiments have been described in the context of fullyfunctioning computing devices, those skilled in the art will appreciatethat the various embodiments are capable of being distributed as aprogram product in a variety of forms. The disclosure applies regardlessof the particular type of machine or computer-readable media used toactually effect the distribution.

Further examples of machine-readable storage media, machine-readablemedia, or computer-readable media include recordable-type media such asvolatile and non-volatile memory devices 1210, floppy and otherremovable disks, hard disk drives, optical disks (e.g., Compact DiskRead-Only Memory (CD-ROMS), Digital Versatile Disks (DVDs)), andtransmission-type media such as digital and analog communication links.

The network adapter 1212 enables the processing system 1200 to mediatedata in a network 1214 with an entity that is external to the processingsystem 1200 through any communication protocol supported by theprocessing system 1200 and the external entity. The network adapter 1212can include a network adaptor card, a wireless network interface card, arouter, an access point, a wireless router, a switch, a multilayerswitch, a protocol converter, a gateway, a bridge, bridge router, a hub,a digital media receiver, and/or a repeater.

The network adapter 1212 may include a firewall that governs and/ormanages permission to access/proxy data in a computer network, andtracks varying levels of trust between different machines and/orapplications. The firewall can be any number of modules having anycombination of hardware and/or software components able to enforce apredetermined set of access rights between a particular set of machinesand applications, machines and machines, and/or applications andapplications (e.g., to regulate the flow of traffic and resource sharingbetween these entities). The firewall may additionally manage and/orhave access to an access control list that details permissions includingthe access and operation rights of an object by an individual, amachine, and/or an application, and the circumstances under which thepermission rights stand.

The techniques introduced here can be implemented by programmablecircuitry (e.g., one or more microprocessors), software and/or firmware,special-purpose hardwired (i.e., non-programmable) circuitry, or acombination of such forms. Special-purpose circuitry can be in the formof one or more application-specific integrated circuits (ASICs),programmable logic devices (PLDs), field-programmable gate arrays(FPGAs), etc.

Integrated Components

In one embodiment, in addition to the “user orienting” features of theside walls which acts to hold or secure the user over a pressurereduction surface (PRS) or perfusion enhancer surface such as, forexample, the pressure mitigation support apparatus 120 of FIG. 1, in aspecific orientation in order to maximize the pressure reduction andredistribution qualities of the surface, the elevated side walls canalso act to hold or secure the user over the entirety of the air cellsof the PRS such that no portion of the air cells of the PRS isuncovered. In other words, no portion of the air cells extend beyond thedownward force of the user. If the air cells are allowed to extendbeyond the downward force, and therefore not be completely covered bythe user, then the air within the air cells could preferentially fillthe portion of the air cell which remained uncovered by the user causinga “ballooning effect” of the uncovered portion of the air cell at theportion not covered by the user.

In one embodiment, the PRS is designed to fit to the size of the user(or fitted). The ballooning of the uncovered portion of the air cellscan defeat the lifting effect produced by the air cells that occurs whenthe air cell is covered in its entirety by the user. Thus, as a resultof the ballooning, increased air pressure within the air cells can berequired to create the desired lifting of the user. Accordingly, in someinstances, the lowest possible internal air pressure that could be usedto lift the user may not be effective in this regard and additional,higher internal pressures could be necessary to perform the lifting. Theincreased pressures that would defeat the pressure reducing aim of thedevice. The side walls act to keep the user on top of the PRS as well asorient the user over that surface. If the side wall did not exist toframe the PRS, then the user would be free to move off the PRS allowingballooning of the air cells on the opposite side and in addition theanatomy of the user's sacral region would not be in correct alignmentwith the geometry of the PRS. The side walls therefore function in thisdual capacity.

In one embodiment, the inflatable portion of the device can have aspecific orientation on top of the mattress or chair upon which it restssuch that there is a side specific to the user contact and a side thatis specific to the contact of the surface upon which it rests. In thisexample, the upward facing side of the PRS has a covering which isbreathable and suited for direct skin contact while the down side of thePRS that is in contact with the mattress or chair is covered with a lessnon-porous material which has a reduced coefficient of friction that isless suitable for direct skin contact. The result of this constructioncan act to protect the user from the negative effects of shear strain onthe skin as the device will preferentially slide over the underlyingsurface as the user stays in position with respect to the device. Thisconstruction can also act to prevent the user from moving from theproper orientation over the PRS of the inflatable portion of the device.

In one embodiment, the maximum pressure reduction and redistribution bythe PRS is achieved when the user is oriented in a specific locationover the pattern of the PRS. The side walls can control the userslocation over the surface in the x axis while the bed, when in aV-position with the legs elevated and the head elevated, acts to centerthe user over the PRS in the y axis.

In one embodiment, the apparatus consists consisting of an inflatableportion (pressure relieving surface), connector tubing and a computercontrolled air pump can be incorporated into a support surface such as amattress. In one embodiment, the additional components can beincorporated or integrated into support surface (e.g., reside within orunder the support surface). Alternatively, the additional components canbe attached to the outer surface of the support surface or mattress suchthe components become an integral part of the support surface withoutbeing inside the support surface. For example, the component can beattached to or attachable to the bed frame which supports the supportsurface or mattress. Alternatively or additionally, some or all of thecomponents can also rest passively on the support surface without beingphysically attached to the support surface.

In one embodiment, the addition of the device (or apparatus) to thesupport surface enhances the functional pressure relief characteristicsof the support surface to which it is added or attached or insertedinto.

In one embodiment, the combination of the device and a support surfacewill not affect the ability of the device to perform its intendedfunction as a pressure relief surface that is designed to orient theusers anatomy with respect to the pattern of the pressure relief surfaceof the device through the use of elevated side walls intended to holdthe users location in a specific manner. The location specificrelationship will enhance the pressure relief capabilities of thedevice.

Computer-Controlled Pump

In one embodiment, a computer controlled pump that controls theinflatable portion of the device can be programmed with the specificweight of the user so as to deliver the correct user-specific pressuresrequired for optimal pressure relief and redistribution for thatparticular user. The pump can continuously adjust the air pressureswithin the inflatable portion of the device so as to achievepredetermined preset internal air pressures within the air cells inorder to achieve the optimal interface pressures between the user andthe pressure relief surface of the device. This process is accomplishedby continuously adding or removing air from the air cells to adjust tothe varying load placed on the pressure relief surface by the user.

In one embodiment, the position of the user (e.g., supine, 30 degrees,90 degrees) is entered into the pump along with the weight of the userso as to calculate the ideal internal air pressures of the air cell ofthe pressure relief surface to produce the ideal pressure reliefcharacteristic for the device. That is the information is provided to apump control device which generates a program that indicates appropriatepressures for each of the air cells over time. The pump control devicethen continuously controls the pump to provide the continuously changingpressures that are indicated by the program.

In one embodiment, the specific nature (e.g., of the stretcher pad—lessthan 3 inches, standard hospital mattress-non powered more than 3inches, alternating pressure air mattress, etc.) of the support surfaceon which the inflatable overlay rests is entered into the computercontrolled air pump in order to calculate the ideal internal pressurefor the air cell of the pressure relief surface in order to produce themost effective pressure relief and redistribution.

In one embodiment, the pre-determined pressure time cycle programmedinto the pump is used to coordinate the inflation and deflation of eachair cell with respect to each other air cell of the inflatable portionof the device so as to produce an effective pressure relief andredistribution surface. The exact internal air pressures for a specificuser can be calculated based the weight of that specific user, thesurface the overlay is resting on, and the position of the bed (e.g., 0degree, 30 degree, 90 degree) on which the overlay rests or isincorporated into. There is an algorithm programmed into the pump whichcalculates the exact pressures used for each user based on thesevariable that are entered for each user.

In one embodiment, the pump can acquire the programmable data regardingutilization, and this data can be sent via direct download or wirelesslyto the computer controlled pump from a central database.

In one embodiment, the pump can utilize a silent valve system so as notto disturb the user.

In one embodiment, the air circulation portion of the inflatable overlayis comprised of a perforated sheet that covers the pressure reliefsurface and is supplied by a separate low pressure high flow pump toproduce air circulating between the surface of the overlay and the userat the interface of the two. In this example, the chamber supplied withhigh flow low pressure air has no pressure relief capabilities and doesnot represent low air loss from the pressure relief air cells that areresponsible for support of the weight of the user as in a low air lossconfiguration where the air in circulation between the user and thesupport surface is leaked directly from the pressure relieving air cellsof the support surface.

In one embodiment, there is a pop off valve in the inflated side wallair cell which contains in a specific location the user over thepressure relief surface of the overlay such that if there is excesspressure placed on the side air wall the internal air is vented from theside air wall so as to prevent a blow out of the side air cell.

In one embodiment, the device can be used solely for the purpose ofcomfort of the user. For example, the device can be used during travelto prevent soreness and/or fatigue associated with long trips such as onairplane or bus or car.

In one embodiment, the pump and/or controller can be powered by ac or dccurrent.

In one embodiment, the device system with one or more of the pump,tubing, and inflatable portion (as described in the original nonprovisional) can be powered by one or more batteries.

In one embodiment, the device can be attached to any support surface,i.e., a chair or a bed. Alternatively or additionally, the device can beincorporated into any support surface, i.e., a bed or a chair.Alternatively or additionally, or the device can placed on top of anysupport surface i.e., a bed or a chair.

In one embodiment, the side walls act to hold the user over the PRS suchthat the entire surface area of the air cells that comprise the PRS iscovered by the downward force of the user in order to prevent theballooning of the air cells in areas not covered by the user by leavingno portion of the air cells uncovered at any location in order toincrease the ability to reduce and redistribute interface pressure atthe lowest internal air cell pressures possible.

In one embodiment, the side of the inflatable portion of the device thatis in contact with the user's skin is breathable and the portion that isin contact with the surface upon which it rests is non-porous and has alow coefficient of friction so as to reduce the shear at the interfacebetween the user and the device while this enables the user to remain inthe proper orientation over the PRS of the device.

In one embodiment, a contact pressure mitigation support apparatusincludes a pressure-mitigating contact portion and a plurality ofelevated side support portions. The pressure-mitigating contact portionis interconnected on a base material and includes a plurality ofindependently pressurized chambers configured in a specific geometricpattern that is designed to mitigate contact pressure between a supportsurface (e.g., bed or chair) and a specific anatomic region of apatient's body when the specific anatomic region of the patient's bodyis oriented over an epicenter of the geometric pattern. The plurality ofelevated side support portions is also interconnected on the basematerial and configured to actively orient the specific anatomic regionof the patient's body over the epicenter of the geometric pattern.

In an embodiment, the contact pressure between the support surface andthe specific anatomic region of the patient's body is mitigated byalternating the pressure in one or more of the plurality ofindependently pressurized relief chambers.

In an embodiment, the elevated side support portions are configured toactively orient the specific anatomic region of the patient's body overthe epicenter of the geometric pattern when pressurized.

In an embodiment, the contact pressure mitigation support apparatusfurther includes one or more straps interconnected on the base material,wherein the one or more straps are configured to secure the pressuremitigation support apparatus to the support surface.

In an embodiment, the contact pressure mitigation support apparatusfurther includes a position sensor interconnected on the base material.The position sensor is configured to confirm that the specific anatomicregion of the patient's body is oriented over the epicenter of thegeometric pattern.

In an embodiment, the contact pressure mitigation support apparatusfurther includes a radio frequency (RF) transceiver interconnected onthe base material and configured to wirelessly transmit the confirmationthat the specific anatomic region of the patient's body is over theepicenter of the geometric pattern and/or receive instructions forindividual chamber pressurization, etc.

In an embodiment, the pressure-mitigating contact portion is contouredto fit the patient's surface topography in the sacral region.

In an embodiment, to fit the patient's surface topography, the pluralityof independently pressurized relief chambers are shorter in height inthe center of the pressure-mitigating contact portion and taller inheight on the edges of the pressure-mitigating contact portion.

In an embodiment, a surface area of the pressure-mitigating contactportion is designed to match the size of contact with the specificanatomic region of the patient's body.

In an embodiment, a surface area of the pressure-mitigating contactportion is designed to be less than the size of contact with thespecific anatomic region of the patient's body.

In an embodiment, the length and the width of the pressure-mitigatingcontact portion are between fifteen and thirty inches.

In an embodiment, the plurality of elevated side support portions areelevated two or more inches in vertical height above the average surfaceheight of the pressure-mitigating contact portion.

In an embodiment, the plurality of elevated side support portions areelevated in vertical height above the average surface height of thepressure-mitigating contact portion so as to create a barrier to lateralmovement.

In an embodiment, the side support portions comprise independentlypressurized chambers.

In an embodiment, the side support portions include a recess to supportthe patient's elbow.

In an embodiment, the independently pressurized relief chambers areconfigured to be independently pressurized with a gas.

In an embodiment, the independently pressurized chambers are configuredto be independently pressurized with a liquid.

In an embodiment, the support surface comprises a mattress.

In an embodiment, the specific anatomic region of the patient's bodycomprises the sacral region.

In an embodiment, to actively orient the specific anatomic region of thepatient's body over the epicenter of the geometric pattern, theplurality of side support portions are configured to confine lateralmovement of the patient.

In an embodiment, to actively orient the specific anatomic region of thepatient's body over the epicenter of the geometric pattern, theepicenter of the geometric pattern is overlaid on a V-shape in thesupport surface such that the epicenter of the apparatus resides overthe low point of the support surface that is conformed into the V-shapeupon which the apparatus rests.

In an embodiment, the anatomic region of the patient's body is segmentedinto various sub-regions and the geometric pattern is configured suchthat each of the independently pressurized chambers correspond to one ofthe various sub-regions.

In an embodiment, the independently pressurized chambers fit to thecorresponding sub-region.

In an embodiment, the geometric pattern is symmetric and non-repeatingin nature.

In an embodiment, the contact pressure mitigation support apparatusincludes one or more channel tubes interconnected on the base material,the channel tubes configured to deliver pressure to the independentlypressurized relief chambers.

In an embodiment, the contact pressure mitigation support apparatusincludes one or more channel tubes interconnected on the base material,the channel tubes can be configured to deliver a gas (i.e., air oroxygen.) from one or more openings in the channel tubes. In this case,the channel tubes are not part of the pressure relieving surface (i.e.,low air loss surface) and the gas delivered from the channel tubes isfrom a source independent from the pressure controlled supply of gas tothe pressurized relief surfaces. That is, the gas delivered by thechannel tubes is high volume and under volume control regulation.

In an embodiment, the one or more channel tubes follow seams between theindependently pressurized relief chambers.

In an embodiment, the seams are recessed between the independentlypressurized relief chambers when one or more of the independentlypressurized relief chambers is pressurized.

In one embodiment, a partial body alternating contact pressure mattressoverlay device is disclosed. The partial body alternating contactpressure mattress overlay device includes a plurality of independentlypressurized chambers, a plurality of elevated side supports, and one ormore straps. The plurality of independently pressurized chambers areconfigured in a geometric pattern that mitigates contact pressurebetween a support surface and a specific anatomic region of a patient'sbody when the specific anatomic region is oriented over an epicenter ofthe geometric pattern. The plurality of elevated side support portionsare configured to actively orient the specific anatomic region over theepicenter of the geometric pattern. The one or more straps areconfigured to secure the pressure mitigation support device to thesupport surface.

In an embodiment, the partial body alternating contact pressure mattressoverlay device further includes a radio frequency identification (RFID)detector configured to configured to detect whether the specificanatomic region of the patient's body is over the epicenter of thegeometric pattern.

In an embodiment, the partial body alternating contact pressure mattressoverlay device further includes one or more pressure sensors configuredto detect the real-time pressure of each of the independentlypressurized chambers.

In one embodiment, an alternating contact pressure mattress includes amattress, a pressure-mitigating contact portion and a plurality ofelevated side support portions. The pressure-mitigating contact portionincludes a plurality of independently pressurized relief chambersinterconnected on the mattress, wherein the independently pressurizedrelief chambers are configured in a geometric pattern that mitigatescontact pressure between a support surface and a specific anatomicregion of a patient's body when the specific anatomic region of thepatient's body is oriented over an epicenter of the geometric pattern.The plurality of elevated side support portions are interconnected onthe mattress and configured to actively orient the specific anatomicregion of the patient's body over the epicenter of the geometricpattern.

In one embodiment, a contact pressure mitigation system is disclosed.The contact pressure mitigation system includes a pressure-mitigatingsupport apparatus and a controller. The pressure-mitigating supportapparatus includes a base material, a pressure-mitigating contactportion including a plurality of independently pressurized reliefchambers interconnected on the base material, wherein the independentlypressurized relief chambers are configured in a geometric pattern thatmitigates contact pressure between a support surface and a specificanatomic region of a patient's body when the specific anatomic region ofthe patient's body is oriented over an epicenter of the geometricpattern, and a plurality of elevated side support portionsinterconnected on the base material, wherein the elevated side supportportions are configured to actively orient the specific anatomic regionof the patient's body over the epicenter of the geometric pattern. Thecontroller is configured to regulate the pressure of each of theindependently pressurized relief chambers.

In one embodiment, a contact pressure-mitigation support apparatusincludes a base material, a pressure-mitigating contact portion, and abiocompatible adhesive portion. The pressure-mitigating contact portioncan include a plurality of independently pressurized relief chambersinterconnected on the base material. The independently pressurizedrelief chambers can be configured in a geometric pattern that mitigatescontact pressure between a support surface and a specific anatomicregion of a patient's body when pressure in the independentlypressurized relief chambers is alternated and the specific anatomicregion of the patient's body is oriented over an epicenter of thegeometric pattern. The biocompatible adhesive portion interconnected onthe base material is configured to actively orient the specific anatomicregion of the patient's body over the epicenter of the geometricpattern.

In an embodiment, the biocompatible adhesive portion extends along atleast a section of the perimeter of the contact pressure-mitigationsupport apparatus. The adhesive may be in direct contact with the skinof the user.

In an embodiment, the biocompatible adhesive portion extends along atleast a section of one or more of the plurality of the independentlypressurized relief chambers.

EXAMPLES

Several aspects of the present technology are set forth in the followingexamples.

1. A system comprising:

-   -   a pressure-mitigation apparatus that includes a geometric        arrangement of inflatable chambers formed by interconnections        between a top layer and a bottom layer,        -   wherein the inflatable chambers are configured to mitigate            contact pressure applied to a human body by a support            surface when pressure in the plurality of inflatable            chambers is varied;    -   a pump fluidly coupled to the chambers and configured to shift a        main point of the contact pressure along a surface of the human        body by sequentially varying the pressure in different subsets        of the inflatable chambers; and    -   a controller operably coupled to the pump and configured to        regulate air flow provided by the pump.        2. The system of example 1 wherein the top layer is comprised of        a first material configured for direct contact with the human        body, and wherein the bottom layer is comprised of a second        material configured for direct contact with the support surface.        3. The system of example 1 wherein the controller is configured        to regulate the air flow provided by the pump based on a weight        of the human body.        4. The system of example 3 wherein the weight of the human body        is programmable by an individual via an interface generated by        the controller.        5. The system of example 1 wherein, upon deployment of the        pressure-mitigation apparatus, the inflatable chambers are        naturally in an inflated state.        6. The system of example 5 wherein the inflatable chambers are        configured to mitigate the contact pressure on an anatomical        region of the human body over time in accordance with a        programmable cycle associated with the anatomical region, and        wherein the programmable cycle causes contact pressure on the        anatomical region to be lessened by controllably deflating at        least one inflatable chamber positioned beneath the anatomical        region.        7. The system of example 1 wherein, upon deployment of the        pressure-mitigation apparatus, the inflatable chambers are        naturally in a deflated state.        8. The system of example 7 wherein the inflatable chambers are        configured to mitigate the contact pressure on an anatomical        region of the human body over time in accordance with a        programmable cycle associated with the anatomical region, and        wherein the programmable cycle causes contact pressure on the        anatomical region to be lessened by controllably inflating at        least one inflatable chamber positioned adjacent the anatomical        region.        9. The system of example 1, further comprising:    -   a wedge configured to actively orient an anatomical region of        the human body lengthwise over an epicenter of the geometric        arrangement.        10. The system of example 1, further comprising:    -   an elevated side support configured to actively orient an        anatomical region of the human body widthwise over the epicenter        of the geometric pattern.        11. The system of example 10, further comprising:    -   a pop-off valve interconnected on the elevated side support,        -   wherein the pop-off valve is configured to release air from            the elevated side support in response to excess pressure on            the elevated side support.            12. The system of example 10, wherein the elevated side            support extends longitudinally along at least one side of            the pressure-mitigation apparatus.            13. An apparatus for mitigating a contact pressure applied            by a support surface to a specific anatomic region of a            human body supported by the support surface, the apparatus            comprising:    -   a first portion designed to face the support surface;    -   a second portion designed to face the human body supported by        the support surface; and    -   a geometric arrangement of inflatable chambers formed via        interconnections between the first and second portions,        -   wherein each inflatable chamber can be independently            pressurized via a discrete airflow, and        -   wherein, upon deployment of the apparatus, a main point of            contact pressure applied by the support surface to the human            body is moved amongst a plurality of locations by            sequentially varying the pressure in different predetermined            subsets of the inflatable chambers.            14. The apparatus of example 13 wherein each predetermined            subset includes at least one inflatable chamber.            15. The apparatus of example 13 wherein the main point of            contact pressure is moved amongst the plurality of locations            in accordance with a predetermined pattern.            16. The apparatus of example 13 wherein the main point of            contact pressure is moved amongst the plurality of locations            in accordance with a random pattern or a semi-random            pattern.            17. The apparatus of example 13 wherein, upon deployment of            the apparatus, the inflatable chambers are naturally in an            inflated state, and wherein the main point of contact            pressure is moved amongst the plurality of locations by            varying a location of at least one deflated chamber.            18. The apparatus of example 13 wherein, upon deployment of            the apparatus, the inflatable chambers are naturally in a            deflated state, and wherein the main point of contact            pressure is moved amongst the plurality of locations by            varying a location of at least one inflated chamber.            19. A method for treating a human body, the method            comprising:    -   diagnosing a condition affecting the human body that causes the        human body to be at least partially immobilized on a support        surface,        -   wherein the support surface applies a contact pressure to            the human body;    -   identifying an appropriate treatment regimen for the condition;    -   disposing a pressure-mitigation apparatus of a pressure        mitigation system between the human body and the support        surface,        -   wherein the pressure-mitigation apparatus includes a            geometric arrangement of inflatable chambers, and        -   wherein the pressure mitigation system comprises a pump            fluidly coupled to the inflatable chambers to deliver a            discrete airflow into each of the inflatable chambers; and    -   shifting a main point of contact pressure applied by the support        surface to the human body by sequentially varying the airflow        delivered to different subsets of the inflatable chambers.        20. The method of example 19 wherein shifting the main point of        contact pressure comprises shifting the main point of contact        pressure periodically to promote increased blood flow throughout        an anatomical region of the human body supported by the        pressure-mitigation apparatus.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

I claim:
 1. A system comprising: a pressure-mitigation apparatus thatincludes a geometric arrangement of inflatable chambers formed byinterconnections between a top layer and a bottom layer, wherein theinflatable chambers are configured to mitigate contact pressure appliedto a human body by a support surface when pressure in the plurality ofinflatable chambers is varied; a pump fluidly coupled to the inflatablechambers and configured to shift a main point of the contact pressurealong a surface of the human body by sequentially varying the pressurein different subsets of the inflatable chambers; and a controlleroperably coupled to the pump and configured to regulate air flowprovided by the pump.
 2. The system of claim 1 wherein the top layer iscomprised of a first material configured for direct contact with thehuman body, and wherein the bottom layer is comprised of a secondmaterial configured for direct contact with the support surface.
 3. Thesystem of claim 1 wherein the controller is configured to regulate theair flow provided by the pump based on a weight of the human body. 4.The system of claim 3 wherein the weight of the human body isprogrammable by an individual via an interface generated by thecontroller.
 5. The system of claim 1 wherein, upon deployment of thepressure-mitigation apparatus, the inflatable chambers are naturally inan inflated state.
 6. The system of claim 5 wherein the inflatablechambers are configured to mitigate the contact pressure on ananatomical region of the human body over time in accordance with aprogrammable cycle associated with the anatomical region, and whereinthe programmable cycle causes contact pressure on the anatomical regionto be lessened by controllably deflating at least one inflatable chamberpositioned beneath the anatomical region.
 7. The system of claim 1wherein, upon deployment of the pressure-mitigation apparatus, theinflatable chambers are naturally in a deflated state.
 8. The system ofclaim 7 wherein the inflatable chambers are configured to mitigate thecontact pressure on an anatomical region of the human body over time inaccordance with a programmable cycle associated with the anatomicalregion, and wherein the programmable cycle causes contact pressure onthe anatomical region to be lessened by controllably inflating at leastone inflatable chamber positioned adjacent the anatomical region.
 9. Thesystem of claim 1, further comprising: a wedge configured to activelyorient an anatomical region of the human body lengthwise over anepicenter of the geometric arrangement.
 10. The system of claim 1,further comprising: an elevated side support configured to activelyorient an anatomical region of the human body widthwise over anepicenter of the geometric pattern.
 11. The system of claim 10, furthercomprising: a pop-off valve interconnected on the elevated side support,wherein the pop-off valve is configured to release air from the elevatedside support in response to excess pressure on the elevated sidesupport.
 12. The system of claim 10, wherein the elevated side supportextends longitudinally along at least one side of thepressure-mitigation apparatus.
 13. An apparatus for mitigating a contactpressure applied by a support surface to a specific anatomic region of ahuman body supported by the support surface, the apparatus comprising: afirst portion designed to face the support surface; a second portiondesigned to face the human body supported by the support surface; and ageometric arrangement of inflatable chambers formed via interconnectionsbetween the first and second portions, wherein each inflatable chambercan be independently pressurized via a discrete airflow, and wherein,upon deployment of the apparatus, a main point of contact pressureapplied by the support surface to the human body is moved amongst aplurality of locations by sequentially varying the pressure in differentpredetermined subsets of the inflatable chambers.
 14. The apparatus ofclaim 13 wherein each predetermined subset includes at least oneinflatable chamber.
 15. The apparatus of claim 13 wherein the main pointof contact pressure is moved amongst the plurality of locations inaccordance with a predetermined pattern.
 16. The apparatus of claim 13wherein the main point of contact pressure is moved amongst theplurality of locations in accordance with a random pattern or asemi-random pattern.
 17. The apparatus of claim 13 wherein, upondeployment of the apparatus, the inflatable chambers are naturally in aninflated state, and wherein the main point of contact pressure is movedamongst the plurality of locations by varying a location of at least onedeflated chamber.
 18. The apparatus of claim 13 wherein, upon deploymentof the apparatus, the inflatable chambers are naturally in a deflatedstate, and wherein the main point of contact pressure is moved amongstthe plurality of locations by varying a location of at least oneinflated chamber.
 19. A method for treating a human body, the methodcomprising: diagnosing a condition affecting the human body that causesthe human body to be at least partially immobilized on a supportsurface, wherein the support surface applies a contact pressure to thehuman body; identifying an appropriate treatment regimen for thecondition; disposing a pressure-mitigation apparatus of a pressuremitigation system between the human body and the support surface,wherein the pressure-mitigation apparatus includes a geometricarrangement of inflatable chambers, and wherein the pressure mitigationsystem comprises a pump fluidly coupled to the inflatable chambers todeliver a discrete airflow into each of the inflatable chambers; andshifting a main point of contact pressure applied by the support surfaceto the human body by sequentially varying the airflow delivered todifferent subsets of the inflatable chambers.
 20. The method of claim 19wherein shifting the main point of contact pressure comprises shiftingthe main point of contact pressure periodically to promote increasedblood flow throughout an anatomical region of the human body supportedby the pressure-mitigation apparatus.